Aspiration systems and methods, and expanding-mouth catheters

ABSTRACT

In some examples, a catheter includes an expandable member configured to expand radially outward from a collapsed configuration to an expanded configuration. The expandable member is configured to be expanded and contracted in a controlled manner, e.g., in response to user actuation or automatically under the control of control circuitry of a device. For example, in some examples, control circuitry of a device can be configured to control the expandable member to expand and contract according to a predetermined expansion frequency or according to an expansion frequency determined based on a cardiac cycle of a patient.

TECHNICAL FIELD

This disclosure relates to a medical catheter.

BACKGROUND

A medical catheter defining at least one lumen has been proposed for usewith various medical procedures. For example, in some cases, a medicalcatheter may be used to access and treat defects in blood vessels, suchas, but not limited to, lesions or occlusions in blood vessels.

SUMMARY

This disclosure describes catheters that include an expandable memberconfigured to expand radially outward from a contracted configuration toan expanded configuration within a vessel of a patient, e.g., to engagea thrombus. For example, the expandable member may include a tubular orcylindrical body configured to radially expand into a larger tubular orcylindrical shape or into a conical shape to more-fully engage athrombus.

In some examples, the expandable member is configured to be expanded andcontracted in a controlled manner, e.g., in response to user actuationor automatically under the control of control circuitry of a device,rather than self-expanding with little to no user intervention. Forexample, in some examples, the expandable member includes a plurality oftensile-actuated axial prongs and/or a basket comprising struts, and theprongs and/or basket are configured to be expanded radially outward inresponse to a tensile force applied to one or more pull membersmechanically coupled to the prongs or basket. Additionally oralternatively, in some examples, the expandable member may include oneor more magnetic elements configured to transition the expandable memberbetween the contracted configuration and the expanded configuration.

This disclosure also describes examples of methods of forming thecatheters described herein and methods of using the catheters.

The details of one or more aspects of the disclosure are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the techniques described in this disclosurewill be apparent from the description and drawings, and from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic diagram illustrating an example aspiration systemincluding an aspiration catheter.

FIG. 1B is a schematic diagram illustrating another example aspirationsystem including an aspiration catheter.

FIG. 2A is a conceptual side view of an example of the aspirationcatheter of FIGS. 1A and 1B, which includes an elongated body and anexpandable member at a distal portion of the elongated body.

FIG. 2B is a conceptual cross-sectional view of the distal portion ofthe elongated body of FIG. 2A, where the cross-section is taken througha center of the elongated body and along a longitudinal axis.

FIGS. 3A and 3B are perspective views of an example expandable member ina contracted configuration at a distal portion of a catheter.

FIG. 3C is a perspective view of the expandable member of FIGS. 3A and3B in an expanded configuration.

FIG. 4 is a conceptual diagram depicting an example method for expandingan expandable member of a catheter.

FIG. 5 is a perspective view of another example expandable member of acatheter.

FIGS. 6A and 6B are conceptual diagrams depicting example methods forexpanding the expandable member of FIG. 5.

FIG. 7 is a perspective view of another example expandable member of acatheter.

FIGS. 8A and 8B are conceptual diagrams depicting example methods forexpanding the expandable member of FIG. 7.

FIG. 9A is a conceptual cross-sectional side view, and FIG. 9B is aconceptual end view, of another example expandable member of a catheterin an expanded configuration.

FIG. 9C is a conceptual cross-sectional side view, and FIG. 9D is aconceptual end view, of the expandable member of FIGS. 9A and 9B in acontracted configuration.

FIG. 10A is a conceptual cross-sectional side view, and FIG. 10B is aconceptual end view of another example expandable member of a catheterin an expanded configuration.

FIG. 11A is a conceptual end view of an example expandable member of acatheter in a contracted configuration.

FIG. 11B is a conceptual end view of the expandable member of FIG. 11Ain an expanded configuration.

FIG. 12A is a conceptual end view of another example expandable memberof a catheter in an expanded configuration.

FIG. 12B is a conceptual end view of the expandable member of FIG. 12Ain a contracted configuration.

FIG. 13A is a conceptual end view of another example of expandablemember in a contracted configuration.

FIG. 13B is a conceptual end view of the expandable member of FIG. 13Ain an expanded configuration.

FIG. 14 is a flow diagram of an example method of forming a catheter.

FIG. 15 is a flow diagram of an example method of using a catheter.

FIG. 16 is a flow diagram of an example method of expanding anexpandable member of a catheter.

DETAILED DESCRIPTION

This disclosure describes catheters and medical aspiration systems(e.g., vascular aspiration systems), as well as methods related tocatheters and aspiration systems. FIG. 1A is a schematic diagramillustrating an example aspiration system 2A including a suction source4, a discharge reservoir 6, control circuitry 8, a memory 9, anaspiration catheter 10, and sensing circuitry 11. Medical aspirationsystem 2A may be used to treat a variety of conditions, includingthrombosis. Thrombosis occurs when a thrombus (e.g., a blood clot orother material such as plaques or foreign bodies) forms and obstructsvasculature of a patient. For example, medical aspiration system 2A maybe used to treat an ischemic insult, which may occur due to occlusion ofa blood vessel (arterial or venous) that deprives brain tissue, hearttissue or other tissues of oxygen-carrying blood.

Aspiration system 2A is configured to remove fluid via catheter 10,e.g., draw fluid from catheter 10 into discharge reservoir 6, via asuction force applied by suction source 4 to catheter 10 (e.g., to aninner lumen of catheter 10). Catheter 10 includes an elongated body 12defining a lumen 22 (FIGS. 2A and 2B) terminating in a mouth 13 (alsoreferred to herein as a distal opening). To treat a patient withthrombosis, a clinician may position mouth 13 of catheter 10 in a bloodvessel of the patient near the thrombus or other occlusion, and apply asuction force (also referred to herein as suction, vacuum force, ornegative pressure) to the catheter 10 (e.g., to one or more lumens ofthe catheter) to engage the thrombus with suction force at mouth 13 ofthe catheter. For example, suction source 4 can be configured to createa negative pressure within inner lumen 22 (FIG. 2A) of catheter 10 todraw a fluid, such as blood, an aspiration fluid, more solid material,or a mixture thereof, into inner lumen 22 via mouth 13 of catheter 10.The negative pressure within inner lumen 22 can create a pressuredifferential between inner lumen 22 and the environment external to atleast a distal portion of catheter 10 that causes fluid and othermaterial to be introduced into inner lumen 22 via mouth 13. For example,the fluid may flow from patient vasculature, into inner lumen 22 viamouth 13, and subsequently through aspiration tubing 170 into dischargereservoir 6.

In some examples, aspiration system 2A is also configured to deliverfluid from a fluid source 3 (FIG. 1B), for example, a fluid reservoirdifferent from discharge reservoir 6, through inner lumen 22 of catheter10 via a positive pressure applied by suction source 4.

As used herein, “suction force” is intended to include within its scoperelated concepts such as suction pressure, vacuum force, vacuumpressure, negative pressure, fluid flow rate, and the like. A suctionforce can be generated by a vacuum, e.g. by creating a partial vacuumwithin a sealed volume fluidically connected to a catheter, or by directdisplacement of liquid in a catheter or tubing via (e.g.) a peristalticpump, or otherwise. Accordingly, suction forces or suction as specifiedherein can be measured, estimated, computed, etc. without need fordirect sensing or measurement of force. A “higher,” “greater,” or“larger” (or “lower,” “lesser,” or “smaller”) suction force describedherein may refer to the absolute value of the negative pressuregenerated by the suction source on a catheter or another component, suchas a discharge reservoir 6.

In some examples, suction source 4 can comprise a pump 5 (FIG. 1B). Thesuction source 4 can include a direct-acting pump, which acts directlyon a liquid to be displaced, or a tube containing the liquid. Adirect-displacement pump can comprise a peristaltic pump, or a lobe,vane, gear, or piston pump, or other suitable pumps of this type. A pumpcan also comprise an indirect-acting pump, which acts indirectly on theliquid to be displaced. An indirect-acting pump can comprise a vacuumpump, which creates a partial vacuum in an evacuation volume fluidicallycoupled to the liquid to be displaced. The vacuum pump displaces acompressible fluid (e.g., a gas such as air) from the evacuation volume(e.g., discharge reservoir 6, which can comprise a canister), generatingsuction force on the liquid. Accordingly, the evacuation volume (whenpresent) can be considered part of the suction source. In otherexamples, suction source 4 can also comprise a pulsator 7, as shown anddescribed with reference to FIG. 1B.

Control, operation, etc. of suction source 4 can comprise control,operation, and the like, of any one or combination of the component(s)making up the suction source. Accordingly, in examples in which suctionsource 4 includes a pump, evacuation volume, and pulsator, control ofthe suction source can comprise control of only the pump, of only theevacuation volume, or of only the pulsator, or of any combination ofthose components. As In examples in which suction source 4 includes onlya pump, control of suction source 4 comprises control of the pump.Control of other suction sources may comprise control of only thepulsator, or of only the evacuation volume, or of only the pump, or ofany combination of the components which are employed in the suctionsource.

Once mouth 13 of aspiration catheter 10 has engaged the thrombus, theclinician may remove aspiration catheter 10 with the thrombus heldwithin mouth 13 or attached to the distal tip of elongated body 12, orsuction off pieces of the thrombus (or the thrombus as a whole) untilthe thrombus is removed from the blood vessel of the patient through alumen of aspiration catheter 10 itself and/or through the lumen of anouter catheter in which aspiration catheter 10 is at least partiallypositioned. The outer catheter can be, for example, a guide catheterconfigured to provide additional structural support to the aspirationcatheter. The aspiration of the thrombus may be part of an aspirationprocedure, such as, but not limited to, a medical procedure using ADirect Aspiration First Pass Technique (ADAPT) for acute strokethrombectomy, or any other procedure for aspiration of thrombus or othermaterial from the neurovasculature or other blood vessels. In addition,aspiration of thrombus can be performed concurrently with use of athrombectomy device, such as a stent retriever, to facilitate removal ofthrombus via mechanical thrombectomy as well as via aspiration.

Suction source 4 can have any suitable configuration. For example, thepump (as well as pumps generally within the present disclosure) caninclude one or more of a positive displacement pump (e.g., a peristalticpump, a rotary pump, a reciprocating pump, or a linear pump), acentrifugal pump, and the like. In some examples, suction source 4includes a motor driven pump, while in other examples, suction source 4can include a syringe configured to be controlled by control circuitry8, and mechanical elements such as linear actuators, stepper motors,etc. As further examples, the suction source 4 could comprise a wateraspiration venturi or ejector jet.

In some examples, suction source 4 may be configured for bi-directionaloperation. For example, suction source 4 may be configured to create anegative pressure that draws fluid from inner lumen 22 of catheter 10 ina first flow direction and create a positive pressure that pumps fluidto catheter 10 and through inner lumen 22 in a second, opposite flowdirection. As an example of this bi-directional operation, an operatorof aspiration system 2A may operate suction source 4 to pump anaspiration/irrigating fluid, such as saline, from an aspiration fluidreservoir 3 (FIG. 1B) to flush and/or prime catheter 10 (e.g., aninfusion state) and subsequently draw fluid from a site of mouth 13 ofcatheter 10, such as saline and/or blood, into discharge reservoir 6.

Control circuitry 8 is configured to control a suction force applied bysuction source 4 to catheter 10. For example, control circuitry 8 can beconfigured to directly control an operation of suction source 4 to varythe suction force applied by suction source 4 to inner lumen 22, e.g. bycontrolling the motor speed, or stroke length, volume or frequency, orother operating parameters, of suction source 4. As another example, asdescribed with reference to FIG. 1B, control circuitry 8 can beconfigured to control a pulsator (e.g., valve) that modifies the suctionforce applied by suction source 4 to inner lumen 22 of catheter 10.Other techniques for modifying a suction force applied by suction source4 to inner lumen 22 of catheter 10 can be used in other examples.

Control circuitry 8, as well as other processors, processing circuitry,controllers, control circuitry, and the like, described herein, mayinclude any combination of integrated circuitry, discrete logiccircuitry, analog circuitry, such as one or more microprocessors,digital signal processors (DSPs), application specific integratedcircuits (ASICs), or field-programmable gate arrays (FPGAs). In someexamples, control circuitry 8 may include multiple components, such asany combination of one or more microprocessors, one or more DSPs, one ormore ASICs, or one or more FPGAs, as well as other discrete orintegrated logic circuitry, and/or analog circuitry.

Memory 9 may store program instructions, such as software, which mayinclude one or more program modules, which are executable by controlcircuitry 8. When executed by control circuitry 8, such programinstructions may cause control circuitry 8 to provide the functionalityascribed to control circuitry 8 herein. The program instructions may beembodied in software and/or firmware. Memory 9, as well as othermemories described herein, may include any volatile, non-volatile,magnetic, optical, or electrical media, such as a random access memory(RAM), read-only memory (ROM), non-volatile RAM (NVRAM),electrically-erasable programmable ROM (EEPROM), flash memory, or anyother digital media.

In some examples, aspiration system 2A includes sensing circuitry 11,which is configured to generate signals (also referred to hereinphysiological signals) indicative of physiological parameters andcommunicate the physiological signals to control circuitry 8. Sensingcircuitry 11 may include any sensing hardware configured to sense aphysiological parameter of a patient, such as, but not limited to, oneor more electrodes, optical receivers, pressure sensors, blood pressurecuffs, or the like. In some examples, the sensed physiological signalsmay include signals indicative of a cardiac cycle of a patient, such as,but not limited to, an electrocardiogram (ECG), an electrogram (EGM), aphotoplethysmogram (PPG), or a blood pressure signal. Thus, in someexamples, sensing circuitry 11 can be configured to include any suitablehardware configured to sense an electrical cardiac signal, bloodpressure, or blood oxygen saturation (e.g., pulse oximetry) of apatient.

In some examples, sensing circuitry 11 and/or control circuitry 8 mayinclude signal processing circuitry configured to perform any suitableanalog conditioning of the sensed physiological signals. For example,sensing circuitry 11 may communicate to control circuitry 8 an unaltered(e.g., raw) signal. Control circuitry 8 may be configured to modify araw signal to a usable signal by, for example, filtering (e.g., lowpass, high pass, band pass, notch, or any other suitable filtering),amplifying, performing an operation on the received signal (e.g., takinga derivative, averaging), performing any other suitable signalconditioning (e.g., converting a current signal to a voltage signal), orany combination thereof. In some examples, the conditioned analogsignals may be processed by an analog-to-digital converter of controlcircuitry 8 or other component to convert the conditioned analog signalsinto digital signals. In some examples, control circuitry 8 may operateon the analog or digital form of the signals to separate out differentcomponents of the signals. In some examples, sensing circuitry 11 and/orcontrol circuitry 8 may perform any suitable digital conditioning of theconverted digital signals, such as low pass, high pass, band pass,notch, averaging, or any other suitable filtering, amplifying,performing an operation on the signal, performing any other suitabledigital conditioning, or any combination thereof. Additionally oralternatively, sensing circuitry 11 may include signal processingcircuitry to modify one or more raw signals and communicate to controlcircuitry 8 one or more modified signals.

In some examples, sensing circuitry 11 includes an ECG sensor, whichincludes electrodes with which control circuitry 8 may detect anelectrical cardiac signal indicative of electrical activity of a heartof a patient. In addition to or instead of the ECG sensor, in someexamples, sensing circuitry 11 includes a blood oxygen saturation sensorwith which control circuitry 8 can sense blood oxygen saturation levelsof a patient and generate an oxygen saturation signal indicative ofblood oxygen saturation within the venous, arterial, and/or capillarysystems within a region of the patient. For example, sensing circuitry11 may include a sensor configured to non-invasively generate a PPGsignal. One example of such a sensor may be one or more oximetry sensors(e.g., one or more pulse oximetry sensors) configured to be placed atone or multiple locations on a patient, such as at a fingertip of thepatient, an earlobe of the patient, and the like.

In addition to or instead of the ECG sensor and/or a blood oxygensaturation sensor, sensing circuitry 11 may include a blood pressuresensor with which control circuitry 8 can sense a blood pressure of apatient and generates a blood pressure signal indicative of the sensedblood pressure. For example, blood pressure sensor may include acontinuous noninvasive blood pressure monitor and/or an arterial lineconfigured to invasively (e.g. endoluminally) monitor blood pressure inan artery of the patient. In some examples, the blood pressure signalmay include at least a portion of a waveform of the arterial bloodpressure.

In addition to or instead of the examples of sensors described above,sensing circuitry 11 can include an acoustic sensor configured to senseheart sounds with which control circuitry 8 or other control circuitrycan determine a cardiac cycle of a patient. As one non-limiting example,sensing circuitry 11 may include a transcranial doppler, configured togenerate a signal indicative of cranial blood flow rates usingultrasound.

Sensing circuitry 11 can be part of a device that includes controlcircuitry 8 or device separate from the device that includes controlcircuitry 8, such as another device co-located with the device thatincludes control circuitry 8 or remotely located relative to the devicethat includes control circuitry 8.

In some examples, control circuitry 8 operatively coupled to sensingcircuitry 11 and is configured to control an operation of sensingcircuitry 11. For example, control circuitry 8 may be configured toprovide timing control signals to coordinate operation of sensingcircuitry 11. In other examples, control circuitry 8 does not controlthe operation of sensing circuitry 11.

As discussed with reference to FIG. 16, in some examples, controlcircuitry 8 is configured to receive one or more signals generated bysensing circuitry 11 and indicative of a cardiac cycle of a patient, andcontrol suction source 4 based on the signals.

FIG. 1B is a schematic diagram of another example aspiration system 2B,which is similar in structure and function to system 2A (FIG. 1A) exceptas further discussed herein. Aspiration system 2B includes catheter 10,aspiration tubing 15, 120, 122, a suction source which can beimplemented in part as a pump 5, and discharge reservoir 6. In addition,aspiration system 2B includes control circuitry 8, memory 9, and sensingcircuitry 11. Aspiration system 2B further comprise a pulsator 7 (whichcan be implemented as valve 176, or otherwise), a flow restrictor 178, afluid source reservoir 3 connected to pulsator 7 via tubing 132, and anactuator 182.

Pulsator 7 can be employed to switch on, switch off, vary, oscillate,pulse, etc. the application of suction force from a suction source,which is shown as a pump 5 in FIG. 1B, to catheter 10. Accordingly,pulsator 7 can fluidically couple or uncouple catheter 10 to or frompump 5 as needed. For example, pulsator 7 can be configured to open andclose the connection of catheter 10 to discharge reservoir 6 (e.g., whenno fluid source 3 is present) or alternatingly switch the connection ofcatheter 10 to discharge reservoir 6 and to fluid source 3.

In the example shown in FIG. 1B, control circuitry 8 is configured tocontrol an amount of suction force applied by pump 5 to inner lumen 22of catheter 10 by at least controlling pulsator 7 (e.g., controlling aposition of valve 176). In some examples, pump 5 is configured to applya substantially continuous suction force (e.g., continuous or nearlycontinuous to the extent permitted by the hardware) to dischargereservoir 6, and the amount of this suction force that is transferred toinner lumen 22 of catheter 10 may be adjusted by pulsator 7 (e.g., theposition of valve 176). In other examples, pump 5 is configured to applypulsed aspiration, e.g., by alternating within a repeating cycle between“on” and “off” phases (during the latter of which no suction force, orreduced suction force is applied to tubing 122), rather than applying asubstantially continuous suction force. The pulsed aspiration can beused alone or in combination with pulsator 7 to vary the amount ofsuction force applied to inner lumen 22 of catheter 10, e.g., toaspirate a clot from vasculature of a patient.

Pulsator 7 can have any suitable configuration, such as, but not limitedto, a valve, tubing clamp, tubing pincher, fluid switch, or the like,configured for selective actuation as needed to fluidically couple oruncouple catheter 10 to or from pump 5 in accordance with control ofaspiration system 2B. In the example shown in FIG. 1B, pulsator 7includes a valve 176, which is movable between at least a first positionand a second position. For example, valve 176 can be a two-positionthree-way valve, such as a three-way ball valve or another suitablevalve, e.g., a pinch, poppet, diaphragm, butterfly, slide, or pistonvalve. Another suitable valve type is a 1-way or 2-way valve equippedwith a relief vent (in which case the fluid source 3 can be omittedalong with flow restrictor 178 and the connection to the valve 176). Inthe first position, valve 176 fluidically couples catheter 10 and fluidsource reservoir 3, and catheter 10 and pump 5 are not fluidicallycoupled. Thus, in the first position of valve 176, pump 5 does not applya suction force to inner lumen 22 of catheter 10 and does not draw fluidfrom inner lumen 22 into discharge reservoir 6. Fluid source reservoir 3can store an incompressible fluid, such as saline; alternatively, it canbe a source of compressible fluid such as a vent to ambient air viatubing 132. Fluid source reservoir 3, when present, can be vented to anexternal environment.

When valve 176 is in its first position, fluid source reservoir 3 isfluidically coupled to inner lumen 22 of catheter 10, thereby relievingany negative pressure in catheter 10 or tubing 15, or otherwise allowingcatheter 10 and tubing 15 to equalize with ambient pressure or a desiredbaseline pressure. In addition, when valve 176 is in its first position,pump 5 is configured to apply a negative pressure to tubing 122, whichcreates and/or maintains a negative pressure in discharge reservoir 6.Control circuitry 8 or a clinician can adjust a setting of flowrestrictor 178 (when present) in order to adjust a rate of fluid flowfrom fluid source reservoir 3 to catheter 10 and/or tubing 15 when valve176 is in its first position (and intermediary positions, as discussedin further detail below).

In the second position of valve 176, valve 176 fluidically couples pump5 and inner lumen 22 of catheter 10, and discharge reservoir 6 and fluidsource reservoir 3 are not fluidically coupled to each other. Thus, inthe second position of valve 176, pump 5 (via discharge reservoir 6) canapply a suction force to inner lumen 22 of catheter 10 and draw fluidfrom inner lumen 22 into discharge reservoir 6.

In some examples, valve 176 is also configured to assume positionsbetween the first and second positions. In such intermediary positions,valve 176 is configured to permit some fluid flow from fluid sourcereservoir 3 to catheter 10 (the fluid flow being less than that observedwhen valve 176 is in its first position) and, at the same time, topermit some fluid flow from the inner lumen of catheter 10 to dischargereservoir 6 (the fluid flow being less than that observed when valve 176is in its second position).

In addition, in some examples, fluid source reservoir 3 can be omittedalong with flow restrictor 178 and the connection to the valve 176,which can take the form of a conventional two-way valve rather than thethree-way valve depicted in FIG. 1B.

Control circuitry 8 is configured to control a position of valve 176 inorder to control an amount of suction force applied by pump 5 to innerlumen 22 of catheter 10 using any suitable technique. In the exampleshown in FIG. 1B, valve 176 is configured to be actuated between thefirst and second positions, including any intermediary positions, basedon an amount of current applied (and/or signal(s) passed) to actuator182. In some examples, actuator 182 can comprise a solenoid; in suchexamples, valve 176 can be referred to as a solenoid valve. Actuator 182can alternatively comprise a linear or rotary actuator, servo, steppermotor, piezoelectric element(s), etc., or any other suitablecomponent(s), or any combination of the foregoing. Control circuitry 8can control an amount of current applied to (and/or pass signal(s) to)actuator 182 in order to modify a position of valve 176.

As detailed further below, in some examples, control circuitry 8 isconfigured to control pulsator 7 (e.g., a position of valve 176) tomodify a suction force applied by pump 5 to lumen 22 of catheter 10based on a particular timing, which can be referred to as suctionfrequency. The suction frequency can be a fixed frequency over a periodof time or can vary over the period of time.

In other examples, pulsator 7 employed in the system 2B of FIG. 1B cancomprise one or more pinch valves. For example, a first pinch valve canbe operatively coupled to tubing 120 and a second pinch valve can beoperatively coupled to tubing 132. Control circuitry 8 can be configuredto control such pinch valves to open and close tubing 120 and tubing 132at appropriate times in accordance with the control techniques disclosedherein. In a first position of pulsator 7, the first pinch valve is openand the second pinch valve is closed, and in a second position ofpulsator 7, the first pinch valve is closed and the second pinch valveis open. Tubing 132 can be connected to fluid source reservoir 3, withor without flow restrictor 178, or tubing 132 can terminate in anopening to ambient air. A check valve can be operatively coupled totubing 132 on the side of the second pinch valve opposite the connectionto tubing 120. The first and second pinch valves can be implemented witha common actuator forming a dual-acting pinch valve that alternatinglyopens and closes the first and second pinch valves.

FIGS. 2A and 2B illustrate an example of aspiration catheter 10 of FIGS.1A and 1B, which includes elongated body 12, a handle 14 proximal toelongated body 12, and expandable member 18 at a distal portion 16B ofthe elongated body 12. As shown in FIG. 2A, catheter 10 includes arelatively flexible elongated body 12 configured to be navigated throughvasculature of a patient, e.g., tortuous vasculature in a brain of thepatient. In examples described herein, a distal portion 16B of elongatedbody 12 includes an expandable member 18, such as an expandable funnel,an expandable tubular shape configured to radially expand into a largertubular shape, or other expandable structure, configured to expandradially outward within a vessel of the patient. This may enable, forexample, expandable member 18 to engage with a clot (e.g., thrombus orembolism) during an aspiration procedure.

Expandable member 18 may help improve aspiration of the clot into thecatheter 10 by providing a relatively large diameter (or othercross-sectional dimension) and interior space for the clot to engagewith the elongated body compared to examples in which an otherwisesimilar catheter does not include an expandable member. For example,such a catheter that does not include an expandable member may have morelimited (or no) radial expansion capability, and may thus make it harderto aspirate a clot (e.g., due to a smaller cross-sectional dimension ofthe distal end of the catheter). Expandable member 18 may overcome suchradial expansion limitations, including by increasing clot engagement,reducing the amount of time required for revascularization, and increaserevascularization success rates for various procedures, as compared tosimilar procedures used with catheters that do not include an expandablemember to engage a clot. For example, expandable member 18 may beconfigured to radially expand along part (e.g., over 50%) or all of itsaxial length, forming an enlarged tubular or cylindrical shape, so as tolargely envelop a clot within the vasculature. An expandable member 18that is configured to assume a tubular or cylindrical shape in anexpanded configuration, as opposed to a more conical shape, may enable alength of the expanded distal portion of catheter 10 to be increased,which can enable expandable member 18 to envelop more thrombus material.This can further contribute to the overall clot engagement and reduce anamount of time required for revascularization.

In some examples, expandable member 18 includes one or more structuralfeatures that enable the expandable member to convert between acontracted configuration and an expanded configuration. For example,expandable member 18 may include any or all of a set of tensile-actuatedaxial prongs, a basket having circumferential expansion struts, and/orone or more magnetic elements configured to transition the expandablemember between the contracted configuration and the expandedconfiguration. In the contracted configuration, expandable member 18 hasa lower profile than in the expanded configuration. To transition fromthe contracted configuration (also referred to herein as a contractedstate, a collapsed configuration or state, or a compressed configurationor state), expandable member 18 expands radially outward away fromcentral longitudinal axis 26 of elongated body 12. In some examples, acontrol unit, such as control circuitry 8 of FIGS. 1A and 1B, may causeexpandable member 18 to expand and contract, such as in a cyclic orperiodic manner.

Elongated body 12 is configured to be advanced through vasculature of apatient via a pushing force applied to proximal portion 16A (e.g., viahandle 14) of elongated body 12, e.g., while resisting undesirabledeformation such as buckling or kinking. In some examples, elongatedbody 12 includes an inner liner 28, an outer jacket 32, and a structuralsupport member 30 (FIG. 2B) positioned between at least a portion of theinner liner 28 and at least a portion of the outer jacket 32. At distalportion 16B, elongated body 12 includes an expandable member 18configured to radially expand within a vessel of a patient, e.g., toengage a clot within the vessel.

Elongated body 12 extends from proximal end 12A to distal end 12B anddefines at least one inner lumen 22. In the example shown in FIG. 2A,proximal end 12A of elongated body 12 is mechanically connected tohandle 14 via an adhesive, welding, or another suitable technique orcombination of techniques. Handle 14 may define an inner lumen 23(referred to herein as a “handle lumen”) in fluid communication withinner lumen 22 of elongated body 12. Catheter 10 may be used as anaspiration catheter to remove a clot or other material such as plaquesor foreign bodies from vasculature of a patient. In such examples, asuction force may be applied to a handle lumen 23, e.g., at proximal end14A of handle 14 (e.g., via side port 24), to draw a clot or otherblockage into inner lumen 22 of elongated body 12 via mouth 13 (e.g., adistal-most opening) of catheter 10. An aspiration catheter may be usedin various medical procedures, such as a medical procedure to treat anischemic insult, which may occur due to occlusion of a blood vessel(arterial or venous) that deprives brain tissue, heart tissue or othertissues of oxygen-carrying blood.

Catheter 10 is configured to be navigated to any suitable vasculaturesite in a patient. In some examples, catheter 10 is configured to accessrelatively distal locations in a patient including, for example, themiddle cerebral artery (MCA), internal carotid artery (ICA), the Circleof Willis, and tissue sites more distal than the MCA, ICA, and theCircle of Willis. The MCA, as well as other vasculature in the brain orother relatively distal tissue sites (e.g., relative to the vascularaccess point), may be relatively difficult to reach with a catheter, dueat least in part to the tortuous pathway (e.g., comprising relativelysharp twists or turns) through the vasculature to reach these tissuesites. Elongated body 12 may be structurally configured to be relativelyflexible, pushable, and relatively kink- and buckle-resistant, so thatit may resist buckling when a pushing force is applied to a relativelyproximal section of catheter 10 (e.g., via handle 14) to advanceelongated body 12 distally through vasculature, and so that it mayresist kinking when traversing around a tight turn in the vasculature.In some examples, elongated body 12 is configured to substantiallyconform to the curvature of the vasculature. In addition, in someexamples, elongated body 12 has a column strength and flexibility thatallow at least distal portion 16B of elongated body 12 to be navigatedfrom a femoral artery, through the aorta of the patient, and into theintracranial vascular system of the patient, e.g., to reach a relativelydistal treatment site. Alternatively, the elongated body can have acolumn strength (and/or be otherwise configured) to enable the distalportion 16B of elongated body 12 to be navigated from a radial arteryvia an access site in the arm, e.g. at or near the wrist, through theaorta of the patient or otherwise to a common carotid or vertebralartery, and into the intracranial vascular system of the patient, e.g.,to reach a relatively distal treatment site.

Although primarily described as being used to reach relatively distalvasculature sites, catheter 10 may also be configured to be used withother target tissue sites. For example, catheter 10 may be used toaccess tissue sites throughout the coronary and peripheral vasculature,the gastrointestinal tract, the urethra, ureters, fallopian tubes, veinsand other body lumens.

A length of catheter 10 may depend on the location of the target tissuesite within the body of a patient or may depend on the medical procedurefor which catheter 10 is used. In some examples, catheter 10 may bedescribed in terms of the working length of elongated body 12. Theworking length of elongated body 12 may be measured from distal end 14Bof handle 14 to distal end 12B of elongated body 12 along a centrallongitudinal axis 26 of elongated body 12. For example, if catheter 10is a distal-access catheter used to access vasculature in a brain of apatient from a femoral artery access point at the groin of the patient,then elongated body 12 may have a working length of about 115centimeters (cm) to about 145 cm or more, such as about 130 cm, althoughother lengths may be used (e.g., in the case of a radial accesscatheter). Distal portion 16B may be about 5 cm to about 35 cm inlength. The length of distal portion 16B may include the length ofexpandable member 18. Proximal portion 16A may be about 90 cm to about130 cm in length, depending on the length of distal portion 16B.

Handle 14 may be positioned at a proximal portion 16A of elongated body12. Handle 14 may define the proximal end 14A of catheter 10. In someexamples, handle 14 may include a luer connector, a hemostasis valve, oranother mechanism or combination of mechanisms for connecting to anotherdevice such as suction source 4 (FIG. 1A) for performing the aspirationtechniques described herein. For example, suction source 4 may befluidically connected to side port 24 of handle 14. In some examples,proximal end 14A of catheter 10 can include another structure inaddition to, or instead of, handle 14, such as a catheter hub.

In some cases, a clinician may steer catheter 10 through the vasculatureof a patient by pushing or rotating handle 14 and/or proximal portion16A of catheter 10 to navigate distal portion 16B of elongated body 12through the vasculature of a patient. The clinician may apply torque tohandle 14 and/or proximal portion 16A of the catheter 10 (or at least aportion of elongated body 12 that is more proximal than distal portion16B implanted in the patient) in order to rotate distal portion 16B ofcatheter 10.

In some examples, an inner liner 28 of elongated body 12 defines atleast a portion of inner lumen 22 of elongated body 12, inner lumen 22defining a passageway through elongated body 12. As discussed in furtherdetail below, expandable member 18 may also define an inner lumen 25that is fluid communication with inner lumen 22 of elongated body 12. Inthe example shown in FIG. 2B, inner lumen 25 defined by expandablemember 18 distally terminates at a distal-most end of catheter 10. Insome examples, inner lumen 22 may extend over the entire length of innerliner 28 (e.g., from a proximal end to a distal end of the inner liner28). Inner lumen 22 may be sized to receive a medical device (e.g.,another catheter, a guidewire, an embolic protection device, a stent, athrombectomy device, such as a stent retriever, or any combinationthereof), a therapeutic agent, or the like. Inner liner 28 may define asingle inner lumen 22, or multiple inner lumens (e.g., two inner lumensor three inner lumens) of catheter 10.

Inner lumen 22 formed by inner liner 28 may define the inner diameter ofelongated body 12. Although a diameter is primarily referred to as adimension of the inner lumen 22 and an elongated body 12 having acircular cross-section (in a direction orthogonal to a longitudinal axis26 (FIG. 2B) of elongated body 12) is primarily referred to herein, inother examples, elongated body 12 and inner lumen 22 can have othercross-sectional shapes, such as, but not limited to, oval shapes,rectangular shapes, spade shapes, and other non-circular shapes.

The diameter of inner lumen 22 (as measured in a direction perpendicularto longitudinal axis 26 (FIG. 2B) of elongated body 12) may vary basedon the one or more procedures with which catheter 10 may be used. Insome examples, the diameter of inner lumen 22 of elongated body 12, alsoreferred to herein as an inner diameter of elongated body 12 or innerliner 28, may be substantially constant (e.g., constant or nearlyconstant) from proximal end 12A to the proximal end of expandable member18 (e.g., substantially constant apart from the diameter changeassociated with expandable member 18). In some examples, the innerdiameter may be about 1.524 mm (about 0.060 inches) or larger. In otherexamples, the inner diameter may not be constant. For example, the innerdiameter of elongated body 12 may taper from a first inner diameter atproximal end 12A to a second, smaller inner diameter at a more distalsection just proximal to expandable member 18. For example, an innerdiameter of elongated body 12 may taper from a first inner diameter ofabout 0.0685 inches (about 1.74 mm) to a second inner diameter of aboutto 0.0605 inches (about 1.54 mm). The inner diameter may, for example,gradually taper in the direction along longitudinal axis 26, where thetaper can be linear, curved, continuous, or discontinuous, e.g., theinner diameter of inner liner 28 may step-down from the first innerdiameter to the second inner diameter in discrete steps. For example,expandable member 18 may define a tapered distal tip of the elongatedbody 12. As described further below, the inner diameter of the sectionof elongated body 12 that includes expandable member 18 may be largerthan the inner diameter of elongated body 12 within regions proximal toexpandable member 18.

An expandable member 18 that defines a tapered tip in a contractedconfiguration may help center distal portion 16B of elongated body 12around a guidewire or other guide member in lumen 22 of elongated body12, which may help prevent or reduce the occurrence of a catheterledge-effect and improve the ease with which a clinician may guide thecatheter to a relatively distal vasculature treatment site through aseries of tight turns in the vasculature. A ledge-effect may otherwisecause distal end 12B of elongated body 12 to catch on or abrade certainanatomical features as it is advanced through vasculature of thepatient, which may adversely affect the navigability of the catheter. Incontrast to catheters without expandable members at their distal ends,expandable member 18 may enable catheter 10 to maintain a lower profileduring navigation to a target site within vasculature of a patientwithout compromising the size of the inner diameter (or other dimensionif non-circular in cross-section) of mouth 13 during aspiration.

Inner liner 28 may be formed using any suitable material, such as, butnot limited to, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE,e.g., unidirectional ePTFE or bi-directional ePTFE), a fluoropolymer,perfluoroalkyoxy alkane (PFA), fluorinated ethylene propylene (FEP),polyolefin elastomers or any combination thereof. A unidirectional ePTFEmay be stretched in one of the longitudinal or radial directions, and abi-directional ePTFE may be stretched in both the longitudinal andradial directions. Other examples of materials from which inner liner 28may be formed include, but are not limited to, Low Density Polyethylene(LDPE) (e.g., about 42D), a PTFE having a durometer of about 60D, HighDensity Polyethylene (HDPE), or any combination thereof. Some suchpolyolefin materials may have similar coefficients of friction as PTFE,and may be conducive to processing. In some examples, inner liner 28 mayinclude PTFE, which may provide elongated body 12 with a lubriciousinner surface and allow relatively easy delivery of interventionaldevices through the elongated body, removal of a clot, or relativelyeasy tracking of the elongated body over a guide member (e.g., aguidewire or a microcatheter). In some cases, a PTFE inner liner 28 mayimpart stiffness to elongated body 12 to improve various navigationproperties such as the pushability catheter 10 through vasculature ofthe patient.

Elongated body 12 includes one or more structural support members 30positioned over inner liner 28. Structural support member 30 isconfigured to increase the structural integrity of elongated body 12while allowing elongated body 12 to remain relatively flexible. Forexample, structural support member 30 may be configured to helpelongated body 12 substantially maintain its cross-sectional shape(e.g., circular or nearly circular) or at least help prevent elongatedbody 12 from buckling or kinking as it is navigated through tortuousanatomy. Additionally, or alternatively, structural support member 30,together with inner liner 28, and outer jacket 32, may help distributeboth pushing and rotational forces along a length of elongated body 12,which may help prevent kinking of elongated body 12 upon rotation ofbody 12 or help prevent buckling of body 12 upon application of apushing force to body 12. As a result, a clinician may apply pushingforces, rotational forces, or both, to the proximal portion of elongatedbody 12, and such forces may cause a distal portion of elongated body 12to advance distally, rotate, or both, respectively.

Structural support member 30 may include one or more tubular braidedstructures, one or more coil members defining a plurality of turns,e.g., in the shape of a helix, or a combination of a braided structureand a coil member. Thus, although the examples of the disclosureprimarily describe structural support member 30 as a coil, in otherexamples, catheter 10 may include a braided structure instead of a coil,a braided structure in addition to a coil, or a combination thatincludes one or more of each structure. As one example, a proximalportion of structural support member 30 may include a braided structureand a distal portion of structural support member 30 may include a coilmember. In some examples, a braided wire (e.g., a combination of roundwires and flat wires) may provide elongated body 12 with betterovalization resistance and tensile strength compared to other catheterdesigns (e.g., a support element consisting of only one metal coil or abraid consisting of only round wires) and coil structures (e.g., wirecoils) may exhibit better columnar strength (e.g., kink resistance)and/or hoop strength (e.g., resistance to ovalization) compared to othercatheter designs.

Structural support member 30 can be made from any suitable material,such as, but not limited to, a metal (e.g., a nickel titanium alloy(Nitinol), stainless steel, tungsten, titanium, gold, platinum,palladium, tantalum, silver, or a nickel-chromium alloy, acobalt-chromium alloy, or the like), a polymer, a fiber, or anycombination thereof. In some examples, structural support member 30 mayinclude one or more metal wires braided or coiled around inner liner 28.The metal wires may include round wires, flat-round wires, flat wires,or any combination thereof.

In other examples, structural support member 30 may include a spiral cuthypotube that is expanded and positioned over inner liner 28. Asdescribed further below, in some such examples, structural supportmember 30 may be formed integrally with expandable member 18. Forexample, structural support member 30 and expandable member 18 may belaser-cut from the same hypotube, e.g., structural support member 30representing a spiral cut segment of the hypotube and expandable member18 representing a segment cut from the hypotube according to one of theexamples detailed further below.

In some examples, structural support member 30 is positioned proximal toexpandable member 18. In some examples, the distal end of structuralsupport member 30 may abut the proximal end of expandable member 18 andmay be coupled to expandable member 18 (e.g., mechanically coupled orbonded with adhesive, or welded). In other examples, expandable member18 may not be coupled to structural support member 30 or may not be indirect contact (e.g., abutting contact) with structural support member30, although the two members may be in the same radial layer ofelongated body 12. For example, the distal end of structural supportmember 30 may be adjacent to the proximal end of expandable member 18but separated by a relatively small gap. In such examples, structuralsupport member 30 and expandable member 18 may be in the same radiallayer and inner liner 28, outer jacket 32, or both may secure bothexpandable member 18 and structural support member 30 in place alongelongated body 12.

Elongated body 12 also includes outer jacket 32 positioned overstructural support member 30 and inner liner 28, the structural supportmember 30 being positioned between portions of inner liner 28 and outerjacket 32. In some examples, outer jacket 32 may be positioned aroundstructural support member 30 such that outer jacket 32 covers at least apart or all of both inner liner 28 and structural support member 30.Outer jacket 32, together with inner liner 28 and structural supportmember 30, may be configured to define elongated body 12 having thedesired structural characteristics (e.g., flexibility, kink resistance,torque responsiveness, structural integrity, pushability, and columnstrength, which may be a measure of a maximum compressive load that canbe applied to elongated body 12 without taking a permanent set). Forexample, outer jacket 32 may have stiffness characteristics thatcontribute to the desired stiffness profile of elongated body 12. Insome examples in which outer jacket 32 extends over expandable member18, outer jacket 32 is configured to accommodate radial expansion ofexpandable member 18.

Additionally, or alternatively, outer jacket 32 may define a durometergradient (e.g., hardness) along longitudinal axis 26. For example, outerjacket 32 may be defined by a plurality of tubular segments extendingfrom proximal end 12A toward distal end 12B wherein each tubular segmentdefines a different durometer. The durometer gradient of outer jacket 32may be selected to help provide elongated body 12 with the desiredflexibility characteristics. For example, in some examples in whichelongated body 12 increases in flexibility from proximal end 12A towardsdistal end 12B, the durometer gradient of outer jacket 32 may decreasein a direction from proximal end 12A towards distal end 12B. In someexamples, the durometer of outer jacket 32 may be from about 25D toabout 75D. For example, outer jacket 32 may define a durometer gradientfrom proximal end 12A towards distal end 12B that generally decreasesfrom about 75D to about 25D.

In some examples, outer jacket 32 may be formed using any suitablematerial including, but are not limited to, polymers, such as apolyether block amide (e.g., PEBAX®, commercially available from ArkemaGroup of Colombes, France), an aliphatic polyamide (e.g., Grilamid®,commercially available from EMS-Chemie of Sumter, S.C.), anotherthermoplastic elastomer (e.g., a thermoplastic, elastomeric polymerconfigured to accommodate radial expansion of expandable member 18),polyurethanes, polyamides, or other thermoplastic material, orcombinations thereof. In some examples, outer jacket 32 may be formed ofan elastic material, such as polyolefin thermoplastic elastomers,polyurethane elastomeric alloys or silicone, that permits the expansionof expandable member 18. For example, distal section 32B of outer jacket32 extending at least partially coextensive with expandable member 18may be formed with such elastic material.

Outer jacket 32 may be heat shrunk around structural support member 30and, in some examples, at least a portion (e.g., a proximal portion) ofexpandable member 18 to secure the two members in the same radial layer.In some examples, during the heat shrinking of outer jacket 32 aroundstructural support member 30, the material of outer jacket 32 may flowinto at least some of the inner spacings or gaps (e.g., gaps between theadjacent turns of the coils, or between the struts or braids) withinstructural support member 30 or expandable member 18 such that portionsof outer jacket 32 and structural support member 30 or expandable member18 form a pseudo-coextensive layer.

In some examples, distal section 32B of outer jacket 32 is co-axial withexpandable member 18 and is at least partially coextensive withexpandable member 18. In some such examples, as shown in FIG. 2B, distalsection 32B of outer jacket 32 may terminate prior to the distal end ofexpandable member 18, such that expandable member 18 extends distallypast a distal end of outer jacket 32 and distal section 32B is onlypartially coextensive with expandable member 18. In other examples,outer jacket 32 is not coextensive with expandable member and insteadterminates prior to the proximal end of expandable member 18 such thatthere is no overlap between expandable member 18 and outer jacket 32. Inother examples, however, distal section 32B of outer jacket 32 may befully coextensive with expandable member 18 and cover the entire outersurface of expandable member 18.

Although a coating or another material may be applied over the outersurface of outer jacket 32, outer jacket 32 may still substantiallydefine shape and size of the outer surface of elongated body 12. In someexamples, the outer diameter of elongated body 12 may be substantiallyconstant (e.g., constant or nearly constant) along the length ofelongated body 12, excluding the change in diameter created byexpandable member 18. In other examples, the outer diameter of elongatedbody 12 may taper from the first outer diameter within proximal portion16A of elongated body 12 to a second outer diameter at point proximateto the proximal end of expandable member 18 (e.g., at point whereexpandable member 18 is coupled to or positioned next to structuralsupport member 30), and the outer diameter may increase from thereferenced point to a third outer diameter of the section of elongatedbody 12 where expandable member 18 is positioned.

In some examples, the taper of the outer diameter of elongated body 12(e.g., from the first diameter to the second diameter or from the seconddiameter to the third diameter) may be continuous along the length ofelongated body 12, such that an outer surface of elongated body 12defines a smooth transition between different diameter portions. Inother examples, elongated body 12 may define discrete step-downs inouter diameter to define the taper. The size of the discrete step-downsin diameter may be selected to reduce the number of edges that may catchon anatomical features within the vasculature as elongated body 12 isadvanced through vasculature.

A larger-diameter proximal portion of elongated body 12 may providebetter proximal support for elongated body 12, which may help improvethe pushability of elongated body 12. In addition, a generally smallerdiameter within the distal portion (e.g., excluding the diameter ofexpandable member 18) may increase the navigability of elongated body 12through tortuous vasculature. Thus, by reducing the outer diameter ofelongated body 12 from proximal portion 16A to distal portion 16B,elongated body 12 may better traverse through tortuous vasculature whilestill maintaining a relatively high level of proximal pushability. Insome examples, such as when expandable member 18 is in a contractedconfiguration, the outer diameter at distal end 12B may be the same orsmaller than the second outer diameter proximal to distal end 12B. Insome examples, the outer diameter(s) of elongated body 12 is in a rangeof about 3 French to about 10 French, such as about 3 French to about 6French. The measurement term “French,” abbreviated Fr or F, is threetimes the diameter of a device as measured in mm. For example, a 6French diameter is about 2 mm.

Expandable member 18 is positioned at distal portion 16B of elongatedbody 12, such that a distal end of expandable member 18 defines distalend 12B of elongated body 12. Expandable member 18 is configured toprovide a radially expandable mouth 13 at distal end 12B with arelatively large diameter (compared to, for example, proximal portion16A of elongated body 12) and interior space for better engagement witha clot (e.g., thrombus or embolus). For example, expandable member 18may be an expandable tube or funnel. In some examples, catheter 10 maybe used with an aspiration procedure (e.g., ADAPT technique) and thesize and shape of expandable member 18 may enable elongated body 12 tobetter engage a clot by increasing the opening into which the clot maybe received, and/or by distributing the aspiration forces over a greaterportion of the clot rather than a localized area, thereby allowing theclot to be more efficiently aspirated into catheter 10. In addition, fora given suction force applied to inner lumen 25 at proximal end 12A ofelongated body 12, a larger distal opening to inner lumen 25 provided byexpandable member 18 enables a greater suction force to be applied to athrombus, even if a more proximal portion of elongated body 12 has asmaller diameter than the distal opening.

By incorporating expandable member 18 into the design of catheter 10,catheter 10 may offer several advantages over conventional aspirationcatheters. For example, by constructing catheter 10 with only structuralsupport member 30 (e.g., at the exclusion of expandable member 18),catheter 10 may exhibit one or more desired navigability characteristics(e.g., strength, flexibility, kink-resistance, or the like), but wouldexhibit limited-to-no expandability at the distal end. To improve theaspiration efficiency, the diameter of the catheter may be increased toprovide engagement with the clot, but the increased diameter may reducethe overall navigability of the catheter through vasculature of thepatient. The inclusion of expandable member 18 may allow the diameter ofelongated body 12 (e.g., within proximal portion 16A) to remainrelatively small and exhibit the improved navigability characteristicsof a catheter body with a small diameter, while expandable member 18would provide catheter 10 with the improved engagement and suctioncharacteristics that may be attributed to having a large diameter ofmouth 13 at distal end 12B. In some examples, the presence of expandablemember 18 may lead to improved revascularization success rates, such asdue to the improved clot engagement (e.g., to better pull the entiretyof the clot into catheter 10 during aspiration) as described herein.

In some examples, the shape and configuration of expandable member 18may provide better engagement with the clot. In some examples, distalmovement or migration of the clot or other material relative to theexpandable member 18 or catheter 10 is prevented or inhibited by theexpandable member 18. For example, the inner surface of the expandablemember 18 may prevent or inhibit distal movement of the clot/materialrelative to the expandable member 18 or catheter 10. This may involveentanglement of the clot/material in the expandable member 18, and/orfrictional resistance to distal movement of the clot/material by theinner surface of the expandable member 18. For example, an inner surfaceof expandable member 18, e.g., defining lumen 25 and/or on a membrane ifpresent, may define a plurality of engagement members, e.g., teeth orhooks, extending into lumen 25 and configured to engage the clot andproximally draw the clot into the mouth 13 of catheter 10 as expandablemember 18 expands into an expanded configuration or as the clot is drawninto lumen 25 via a suction force applied to lumen 25 by suction source4 (FIG. 1A).

In an expanded configuration, expandable member 18 may define a funnelshape. For example, expandable member 18 may taper from a relativelysmall cross-sectional dimension near the proximal end of expandablemember 18 to a relatively large cross-sectional dimension of mouth 13 atdistal end 12B of elongated body 12. That is, the cross-section ofexpandable member 18 may be wider at a distal end than a proximal end.For example, in the expanded configuration, the distal end of expandablemember 18 may be about 150 percent to about 300 percent wider than aninner diameter of proximal portion 16A of elongated body 12. In someexamples, the cross-sectional shape (taken in a direction orthogonal tolongitudinal axis 26) of expandable member 18 may be round (e.g.,circularly shaped) and the cross-sectional axis may be referred to as adiameter. In other examples, expandable member 18 may have anirregularly shaped cross-section, in which case the cross-sectionaldimension may be referred to as the major dimension (e.g., a longestdimension of the cross-section). Thus, while a major dimension ofexpandable member 18 is primarily referred to as a diameter herein, inother examples, expandable member 18 can have other shapes incross-section.

In an example, the increased diameter of mouth 13 at distal end 12B mayallow for better sealing capabilities with the vessel wall and betterengagement with a clot during aspiration. For example, during aspirationwith a conventional catheter, engagement with the clot may be reduceddue to the relatively small diameter of the catheter at its distal tip.Additionally, due to the size of the catheter relative to the vesseldiameter, spacing between the interior of the vessel wall and theexterior of the catheter can result in a general loss of suction power.In contrast, the increased diameter of expandable member 18 may providebetter sealing with the vessel wall thereby resulting in a reduced lossof suction. Additionally, in examples where the cross-section isgenerally round, the increased diameter and funnel shape of expandablemember 18 may allow for a large portion of the clot to be receivedwithin the inner volume defined by the funnel shape to provide improvedsealing and physical engagement with the clot during the aspirationprocedure.

Expandable member 18 can be made from any suitable material, such as,but not limited to, a metal (e.g., a nickel titanium alloy (Nitinol),stainless steel, tungsten, titanium, gold, platinum, palladium,tantalum, silver, or a nickel-chromium alloy, a cobalt-chromium alloy,or the like), a polymer, a fiber, or any combination thereof. In someexamples, expandable member 18 may be formed from a shape memory metal(e.g., nickel titanium (Nitinol)). As discussed in further detail below,in some examples, expandable member 18 may include one or more magneticmaterials that facilitate expansion and/or contraction of expandablemember 18. The materials of expandable member 18 may be selected so thatonce in an expanded configuration, expandable member 18 substantiallymaintains its shape, even in the presence of the vacuum force applied tocatheter 10 during the aspiration process.

Expandable member 18 may be of any suitable length and diameter, whichmay be selected based on the target vessel or particular procedure beingperformed. In some examples, expandable member 18 may be about 2centimeters to about 25 centimeters long measured in a directionparallel to longitudinal axis 26 and configured to expand to about 150percent to about 300 percent of the outer diameter of its collapsedconfiguration or the diameter of the proximal end of expandable member.As discussed above, in some examples, in the collapsed state, expandablemember 18 may have a cross-sectional dimension equal to or substantiallyequal to the outer diameter of elongated body 12 proximate to expandablemember 18. In an example, expandable member 18 may be about 1.5 cm,about 2.0 cm, or about 2.5 cm in length. In some examples, the expandedouter diameter or the cross-sectional dimension of mouth 13 of elongatedbody 12 at distal end 12B may be about 200 percent, 250 percent, 300percent, or another percentage larger compared to a portion of elongatedbody 12 that includes only structural support member 30 (e.g., thediameter or cross-section at line A-A of FIG. 2B). In some examples, tothe expandability of expandable member 18 at distal portion 16B mayallow the cross-sectional dimension of elongated body 12 within proximalportion 16A to remain comparatively small. As described above, such acombination may enable catheter 10 to exhibit the improved navigabilitycharacteristics of catheter body with a small diameter while stillproviding catheter 10 with the improved engagement and suctioncharacteristics that may be attributed to having a large diameter ofmouth 13 at distal end 12B.

In some examples, expandable member 18 may be mechanically coupled tostructural support member 30 and/or layered between (at least in aproximal portion of the expandable member 18) inner liner 28 and outerjacket 32. For example, expandable member 18 and structural supportmember 30 can be formed independently of one another, and the proximalend of expandable member 18 may be coupled to the distal end ofstructural support member 30. In some examples, expandable member 18 andstructural support member 30 may be joined via welding, brazing,soldering, epoxy, mechanical attachment mechanisms (e.g., hooks) orother suitable technique. In other examples, structural support member30 and expandable member 18 may be integrally formed, e.g., have aunibody configuration. For example, structural support member 30 andexpandable member 18 may be formed using the same hypotube. As anexample, the proximal portion of the hypotube can be spirally cut toform a coil structure (e.g., structural support member 30) while thedistal portion of the hypotube can be cut to form the components of anyof the various examples of expandable member 18 described herein.

Additionally, or alternatively, expandable member 18 may be at leastpartially secured to structural support member 30 via inner liner 28and/or outer jacket 32. For example, expandable member 18 may not bedirectly coupled to structural support member 30 or may not be in directcontact (e.g., abutting contact) with structural support member 30,although the two structures may be in the same radial layer of elongatedbody 12 in some cases. In an example, expandable member 18 may bepositioned adjacent to structural support member 30 over inner liner 28,and outer jacket 32 may be positioned over expandable member 18 andstructural support member 30. For example, outer jacket 32 may beheat-shrunk over expandable member 18 and structural support member 30such that outer jacket 32 secures both expandable member 18 andstructural support member 30 in place relative to inner liner 28. Insuch examples, expandable member 18 may be positioned at least partiallybetween inner liner 28 and outer jacket 32 (e.g., layered or positionedbetween distal section 28B of inner liner 28 and distal section 32B ofouter jacket 32). For example, at least a proximal portion of expandablemember 18 may be positioned between inner liner 28 and outer jacket 32.

One or both of inner liner 28 or outer jacket 32 may extend over theentire length of expandable member 18, may extend over only a portion ofthe length of expandable member 18, or may not overlap with expandablemember 18. For example, distal section 28B of inner liner 28 may extendover only part of the length of expandable member 18 leaving portions ofexpandable member 18 exposed to inner lumen 22. In some cases, theexposed portions of expandable member 18 may provide better engagementwith a clot and/or prevent distal migration of clot from catheter 10 dueto the texture of expandable member 18 or direct electrostaticengagement with expandable member 18. For example, as described in someexamples herein, elongated body 12 may comprise an electrical conductorelectrically coupled to expandable member 18, and expandable member 18may be configured to receive an electrical signal via the conductor thatcauses expandable member 18 to electrostatically engage the clot.

In some examples, an inner surface of expandable member 18 may comprisea surface treatment configured to promote at least one of mechanical orchemical engagement between the inner surface and the clot. In someexamples, a coating may be applied to portions of the inner surface ofexpandable member 18 (e.g., the inner surface of the struts) or theinner surface of inner liner 28, or the surfaces may be textured viaetching or otherwise roughened (or rougher) in comparison to the outersurface of the expandable member 18 to better mechanically engage theclot. In some examples, the inner surface of the distal section 28B ofinner liner 28 may be etched, such as to promote mechanical clotengagement.

In some examples, clot engagement with expandable member 18 may beenhanced by delivering electrical energy to expandable member 18. Forexample, a source of electrical energy (e.g., an electrical signalgenerator) may deliver an electrical signal to expandable member 18 viaone or more electrical conductors (not shown) electrically coupled toexpandable member 18. The electrical energy may be positively charged toelectrostatically engage a clot. Characteristics of the electricalenergy may be adjusted to better engage the clot, such as polarity, oran amount or type of current delivered. For example, pulsed directcurrent may be employed, optionally with a non-square and/ornon-negative waveform. The electrical conductors can extend throughinner lumen 22 of elongated body 12, can extend along an outer surfaceof elongated body 12, can be embedded in a wall of elongated body 12, orhave any other suitable configuration.

Although FIG. 2B illustrates an example in which both inner liner 28 andouter jacket 32 terminate proximal to a distal end of expandable member18, in other examples, inner liner 28 and outer jacket 32 can have otherarrangements relative to expandable member 18. For example, inner liner28 and/or outer jacket 32 may not overlap with expandable member 18 ormay only overlap with a proximal-most portion of expandable member 18that does not expand. As another example, a distal section 28B of innerliner 28 may be fully coextensive with expandable member 18, and/orouter jacket 32 may be fully coextensive with expandable member 18.

Expandable member 18 may expand from a collapsed configuration to anexpanded configuration using any suitable technique, as detailed furtherin the examples below. In some examples, expandable member 18 isconfigured to self-expand. For example, expandable member 18 may beformed from a shape memory material such as Nitinol. Additionally oralternatively, expandable member 18 may include one or more magneticelements enabling expandable member 18 to self-expand in response to theforces of magnetic repulsion and/or attraction. In some such examples,catheter 10 may include a retractable sheath over expandable member 18that helps retain expandable member 18 in a collapsed configuration,e.g., during navigation of elongated body 12 to a target treatment sitewithin the vasculature of a patient. Once at the target treatment site,the retractable sheath may be withdrawn proximally over elongated body12 to allow expandable member 18 to self-expand. In other examples, anelectrical energy may be used to expand expandable member 18. Forexample, expandable member 18 (or a portion or a layer thereof) may beformed from a material or metal that bends or deflects in response to acurrent passed therethrough (or to heat generated as a result of suchcurrent). One such type of material is shape memory alloy actuatormaterial, e.g. nitinol or Flexinol™ available from Dynalloy, Inc. ofIrvine, Calif. USA. In some examples, a control unit, such as controlcircuitry 8 of FIGS. 1A and 1B, may cause expandable member 18 to expandand/or contract, such as in response to receiving user input, orautomatically.

Expandable member 18 may include any of a number of different structuralaspects, components, configurations, or applications described herein.The following examples of expandable member 18 are not mutuallyexclusive, e.g., any or all of the aspects of the various depictedexamples may simultaneously be used in combination with one another.

In some examples, as shown in FIGS. 2A-6B, one example of expandablemember 18 includes a tubular body 33 and a plurality of flexible prongs34 extending axially from tubular body 33 in a distal direction.Expandable member 18 is depicted in a collapsed configuration in FIGS.2A, 3A, 3B, and 5 and in an expanded configuration in FIGS. 2B and 3C.FIGS. 4, 6A, and 6B are conceptual diagrams depicting an “unrolled” or“flattened” expandable member 18 in order to illustrate various examplestructural components of tubular body 33.

Flexible prongs 34 are disposed circumferentially around centrallongitudinal axis 26 of elongated body 12, and may be either evenly orunevenly distributed around the circumference of tubular body 33. Forexample, any two consecutive (e.g., circumferentially adjacent) flexibleprongs 34 may define a gap 35 between them, and any two gaps may beapproximately equal or not equal in size. In some examples, gaps 35 maybe sufficiently small to reduce a probability that a clot or thrombusescapes through the gaps when expandable member 18 is engaged with theclot or thrombus. Flexible prongs 34 may have any suitable length,measured from a respective proximal end 34A to a respective distal end34B (ends 34A, 34B are labeled in FIG. 4). In some examples, eachflexible prong 34 may define a length from about 0.5 cm to about 2.5 cm.

Expandable member 18 may include any number of prongs 34. In someexamples, expandable member 18 includes four to six prongs 34circumferentially spaced around distal end 12B of elongated body 12. Insome examples, prongs 34 may be heat-set so as to define a contractedconfiguration of expandable member 18 in an at-rest state, e.g., when auser has not actuated prongs 34 to expand expandable member 18 to theexpanded configuration. In some examples, in a contracted configurationof expandable member 18, prongs 34 are substantially parallel (e.g.,parallel or nearly parallel to the extent permitted by manufacturingtolerances) with central longitudinal axis 26 of catheter 10. In otherexamples, however, prongs 34 are not parallel with central longitudinalaxis 26 in the collapsed configuration of expandable member 18 and areinstead, for example, angled relative to central longitudinal axis 26.For example, prongs 34 may be curved or angled toward central axis 26 ina distal direction, such that, in a contracted configuration, expandablemember 18 defines a tapered distal tip of elongated body 12, e.g., suchthat distal ends 34B of the prongs 34 are closer to central longitudinalaxis 26 than the proximal ends 34A. In some of these examples, across-sectional dimension of elongated body 12 is smallest near distalend 12B, as compared to a cross-sectional dimension of elongated body 12between proximal end 12A and distal end 12B.

Expandable member 18 (including prongs 34) may be formed using anysuitable technique. In some examples, expandable member 18 is cut (e.g.,laser cut) from a single piece of material, such as a shape memorymaterial (e.g., Nitinol) or stainless steel. In other examples, at leastsome prongs 34 may be formed separate from each other and subsequentlyconnected to each other (e.g., via a tubular body 33) to defineexpandable member 18.

Expandable member 18 is configured to be expanded using one or moretechniques, including via a proximal force pulling back on a part ofexpandable member 18 (e.g., prongs 34), via one or more magneticmaterials incorporated into expandable member, or any combinationthereof. As shown in FIG. 2A, in some examples, catheter 10 may includea user-input device 20 (e.g., a button, dial, lever, switch, joystick,and the like) configured to activate or control expansion and/orcontraction of expandable member 18. In the example of FIG. 2A,user-input device 20 is depicted as a button or slider located on handle14. Other configurations of user-input device 20 can be used in otherexamples, such as a rotatable wheel, as one non-limiting example.

A user may interact with user-input device 20 to manually (e.g.,mechanically) transition expandable member 18 between a contractedconfiguration and an expanded configuration, as detailed further below.For example, a user may slide user-input device 20 within a channeldefined by handle 14 to proximally retract one or more pull membersconnected to expandable member 18 and input device 20 to causeexpandable member 18 to expand radially outward. As another example, auser may rotate a rotatable wheel in one direction to proximally retractone or more pull members connected to expandable member 18 to causeexpandable member 18 to expand radially outward and rotate the rotatablewheel in an opposite direction to cause the pull members to causeexpandable member 18 to move to a contracted configuration.

In other examples, catheter 10 includes control circuitry 8 or isotherwise electrically connected to control circuitry 8 (FIGS. 1 and2A), which is configured to control the expansion and contraction ofexpandable member 18, and user-input device 20 may be communicativelycoupled (e.g., in wired or wireless data communication) with controlcircuitry 8. For example, in response to receiving user input viauser-input device 20, control circuitry 8 may cause expandable member 18to expand and contract. As another example, control circuitry 8 may beconfigured to control expandable member 18 to move between an expandedconfiguration (e.g., a fully expanded configuration or a partiallyexpanded configuration) and contracted (e.g., a fully collapsed orpartially collapsed) configuration based on the expansion frequency. Theexpansion frequency can indicate, for example, the number of timesexpandable member 18 is in the expanded configuration or the contractedconfiguration per unit of time. Thus, the expansion frequency can, insome examples, indicate the timing with which control circuitry 8 causesexpandable member 18 to transition between the expanded configurationand the contracted configuration.

Control circuitry 8 can determine the expansion frequency using anysuitable technique. For example, a clinician may provide input tocontrol circuitry 8 via user-input device 20 or another user inputdevice that indicates a desired expansion frequency at which controlcircuitry 8 cyclically expands and contracts expandable member 18.

In some examples, control circuitry 8 is configured to control theexpansion and contraction of expandable member 18 based on a cardiaccycle of a patient. For example, control circuitry 8 may determine anexpansion timing or expansion frequency based on the cardiac cycle basedon data received from one or more sensors (e.g., part of, or connectedto, sensing circuitry 11 of FIGS. 1A and 1B) configured to detect thecardiac cycle of the patient. For example, control circuitry 8 may beconfigured to determine which part of a cardiac cycle a heart of patientis in and control expandable member 18 to assume an expandedconfiguration or a collapsed configuration during a first part of thecardiac cycle, such as diastole, and to conversely, assume the other ofthe expanded configuration or the collapsed configuration, respectively,contract during a second part of the cardiac cycle, such as systole. Apart of a cardiac cycle can include a portion of the cardiac cycle anddoes not span multiple cardiac cycles. It is believed that controllingthe expansion and contraction of expandable member 18 based on thecardiac cycle of a patient may more quickly and more effectively removea thrombus from a blood vessel of a patient by varying an amount ofsuction force applied to the clot.

Control circuitry 8 can determine the cardiac cycle (e.g., the currentphase of a cardiac cycle) using any suitable technique. For example,control circuitry 8 can determine a current phase of a cardiac cycle ofa patient based on an electrical cardiac signal, a blood pressure, bloodoxygen saturation, or another physiological parameter that changes as afunction of a cardiac cycle of the patient. In some examples, controlcircuitry 8 is otherwise communicatively coupled to sensing circuitry 11configured to generate a signal indicative of a physiological parameterof the patient indicative of the cardiac cycle, and the controlcircuitry is configured to receive the signal and determine the cardiaccycle (e.g., a specific phase of the cardiac cycle) based on the signal.The signal can include, for example, one or more of an ECG, an EGM, aphotoplethysmogram (PPG), a heart sound phonocardiogram, or a bloodpressure signal. The sensing circuitry can include, for example, one ormore of an electrocardiogram sensor, an electrogram sensor, a bloodoxygen saturation sensor, or an arterial blood pressure sensor.

In some examples, control circuitry 8 may additionally be configured tocontrol the amount of suction force applied to catheter 10. For example,control circuitry 8 may be configured to control a suction frequency(e.g., a frequency with which suction source 4 modifies a suction sourcebetween relatively high and relatively low suction forces) and/or thesuction force applied by suction source 4 (FIG. 1A). In such examples,control circuitry 8 may be configured to control the suction frequencyof suction source 4 (FIG. 1A) independently from the expansion frequencyof expandable member 18. In other examples, control circuitry 8 may beconfigured to control the periodic suction force of the pump and thecyclical expansion of expandable member 18 according to a commonfrequency, such as based on the cardiac cycle as described above.

In some examples, catheter 10 may include a sensor (e.g., sensingcircuitry 11 of FIGS. 1A and 1B) configured to detect a naturalfrequency (e.g., a resonant frequency) of a clot within the patient'svasculature. In such examples, control circuitry 8 may control theexpansion frequency of expandable member 18 based on the naturalfrequency of the clot or a surrogate for the natural frequency (e.g., afrequency that corresponds to the natural frequency of the clot) inorder to more-effectively aspirate the clot. For example, sensingcircuitry 11 may include an intravascular vibrometer probe and/or anintravascular ultrasound transducer configured to measure the naturalfrequency of the clot. In some examples, control circuitry 8 and/orsensing circuitry 11 may be configured to indirectly determine (e.g.,estimate) the natural frequency of a clot by measuring one or moreparameters of the clot that are relatively strongly correlated with thenatural frequency, such as the fibrin density of the clot, and thendetermine the natural frequency based on the known correlationrelationship between the measured parameter and the natural frequency.In other examples, a clinician may determine the fibrin content of theclot during pre-procedure imaging, such as through medical imaging(e.g., computerized tomography (CT) imaging or ultrasound imaging),wherein clots having a higher fibrin density may appear relativelybrighter on the CT or other medical images. The clinician may then inputan indication of the determined natural frequency to control circuitry8.

Although shown internal to handle 14 in FIG. 2A, in other examples,control circuitry 8 can be separate from handle 14 and electricallyconnected to components of catheter 10 via a wired or wirelessconnection.

In some examples, as shown in FIGS. 2B-4, expandable member 18 isconfigured to be expanded via at least one actuation member, which isshown in the example of FIGS. 2B-4 as at least one elongated pull member36. Pull member 36 may include a relatively thin filament or wire, suchas made from a metal, polymer, or other relatively robust materialconfigured to withstand a proximal pulling force sufficient to pull backon prongs 34 without breaking. A distal portion (e.g., a distal-mostend) of pull member 36 may be mechanically coupled (e.g., welded, glued,bonded, soldered, tied, adhered, etc.) to at least one prong 34 of theplurality of prongs 34, such that a distal portion or the distal end 34Bof the respective prong 34 is configured to expand radially outwardrelative to the central longitudinal axis 26 in response to a tensileforce (as indicated by the arrows in FIG. 4) applied to pull member 36.For example, pull member 36 may extend proximally from an exteriorsurface of prong 34, through an opening 37 defined by tubular body 33 ofand into an interior of elongated body 12 (e.g., into inner lumen 22and/or between inner liner 28 and outer jacket 32). Within elongatedbody 12, pull member 36 may proximally extend the entire length ofelongated body 12 and into handle 14, for example, into handle lumen 23(FIG. 2A).

As shown in FIG. 2A, handle 14 may include a switch, button, or otheruser-input device 20. In some examples, but not all examples, user-inputdevice 20 may be configured to mechanically apply a proximal tensileforce to a proximal portion (e.g., a proximal end) of pull member 36, inresponse to manual activation by a user. In other examples, user-inputdevice 20 is communicatively coupled to control circuitry 8 (e.g., via amotor under control of control circuitry 8), configured to mechanicallyapply a proximal tensile force to a proximal portion (e.g., a proximalend) of pull member 36, in response to activation of user-input device20 by a user.

In response to the proximal tensile force, pull member 36 distallyretracts distal end 34B of prong 34, causing mouth 13 at the distal-mostend 12B of elongated body 12 to expand radially outward. In this way,the techniques of this disclosure enable a user to open and close thecatheter tip in a predictable and controllable manner. For example, byactuating expandable member 18 to remain in an expanded configuration,the techniques of this disclosure may reduce or prevent the distal end126 of elongated body 12 from collapsing and/or closing in response to aproximal suction force during an aspiration procedure.

In some examples, as shown in FIGS. 2-4, expandable member 18 includes aplurality of pull members 36, wherein a distal portion of each pullmember 36 is mechanically coupled to a respective prong 34. In someexamples, proximal portions of all of the plurality of pull members 36may be coupled together, such that activation of user-input device 20 onhandle 14 applies a proximal force to all of pull members 36simultaneously, causing a radially symmetric expansion of expandablemember 18 (e.g., in examples in which prongs 34 are evenly distributedaround tubular body 33). In other examples, catheter 10 can beconfigured such that one or more pull members 36 may be actuated (e.g.,pulled) individually, enabling a clinician to customize the expandedshape of expandable member 18 and, therefore, the expanded shape ofmouth 13 at distal end 12B of elongated body 12. For example, duringaspiration of a thrombus or clot, a user (e.g., a physician) maydetermine that a particular expanded configuration of expandable member18 may be more efficient or successful by conforming mouth 13 to theshape of the thrombus. Separate control over one or more pull members 36may allow for improved control over the expansion of expandable member18.

As shown in FIGS. 2A-4, in some examples, each of prongs 34 may beformed (e.g., laser-cut) from a relatively thin material (wherein thethickness is measured radially from central longitudinal axis 26). Insome of these examples, as shown in FIG. 3C, each prong 34 is configuredto bend or curve along its entire axial length in response to theproximal force from the respective pull member 36. In other examples,each prong 34 can be configured to bend or curve along only part of itslength.

For example, each prong 34 may be formed or cut into a generally oval,diamond, or flower-petal shape, defining a wider central portion,narrower proximal and distal portions, and an opening 40 extending alonga substantial length of the respective prong 34 (e.g., from proximal end34A toward distal end 34B of each prong 34). For example, as shown inFIGS. 2A-3C, each prong 34 may include a pair of curvilinear members 44.In the example shown in FIG. 4, each prong 34 may include a pair oflinear or V-shaped members 46. In some examples, each prong 34 mayinclude a combination of linear and curvilinear members.

In some examples, but not all examples, directly adjacent prongs may becoupled to one another at one or more points that are located distal totubular body 33. For example, as shown in FIG. 3A, circumferentiallyadjacent prongs 34 may be coupled together at a circumferentially widestpoint 48 of each prong, such that expandable member 18 may only bend,flex, or expand along a region distal to point 48.

In other examples, each of prongs 34 may be formed (e.g., laser-cut)from a relatively thicker material, wherein the thickness is measuredradially from central longitudinal axis 26. For example, as shown inFIGS. 5-6B, each of prongs 34 may be formed (e.g., laser-cut) into agenerally rectangular-prism shape (e.g., having a generally uniformwidth w (FIG. 6B) along its axial length between proximal end 34A anddistal end 34B). In other examples, thicker prongs 34 may include othershapes, such as shapes having non-uniform widths w along theirrespective axial lengths. For example, some or all of the prongs 34 maydecrease in width w in a distal direction, or may increase in width walong its length in a distal direction and then subsequently decrease inwidth w such that prongs 34 define a shape similar to the shapes shownin FIGS. 3A-4.

In examples in which each of prongs 34 may be formed from a relativelythicker material, rather than bending or curving along the entire lengthof the prong 34, each prong 34 may be configured to bend or flex at oneor more designated hinges 41 along the length of the prong 34. Forexamples, hinges 41 may enable controlled bending of prongs 34 in aradial direction, as well as reduce unintended bending of prong 34 inother directions, such as circumferential bending. As an example, hinges41 may each define a pivot point for bending of prongs 34.

Hinges 41 may have any suitable structure configured to provide a regionof preferential bending relative to other regions of the prong 34. Forexample, each of hinges 41 may include one or more openings cut into amaterial of the respective prong 34, weakening that particular sectionof the prong 34, enabling it to bend in response to the tensile forcefrom the pull member 36. Each prong 34 may include one hinge 41 (asshown in FIGS. 5 and 6A), two hinges 41 (as shown in FIG. 6B), or morethan two hinges 41. In some examples, as shown in FIGS. 6A and 6B, ahinge 41 may be located at a proximal-most edge of the respective prong34. In other examples, a hinge 41 may be located elsewhere along theaxial length of the respective prong 34 (e.g., between proximal end 34Aand distal end 34B). The axial location of hinges 41 may affect a sizeand/or shape of the resulting expanded configuration of expandablemember 18.

As shown in FIG. 3A, in some examples, expandable member 18 may define arelatively uniform circumference (e.g., uniform radius extending fromcentral axis 26) when in a contracted configuration. In other examples,such as the example of FIG. 3B, expandable member 18 may taper towarddistal end 12B of elongated body 12, while in a contractedconfiguration.

As shown in FIGS. 3B, 5, 6A, and 6B, in some examples, each prong 34 maydefine one or more distal openings 42. Distal openings 42 are configuredto receive a distal-most end of a respective pull member 36. Forexample, as shown in FIG. 3B, pull member 36 may distally extend from anexterior surface of each prong 34 and through a distal opening 42, wherethe distal-most end of pull member 36 may be attached (e.g., welded,etc.) to an interior surface of the respective prong 34. In otherexamples, such as shown in FIGS. 3A and 3C, the distal-most end of eachpull member 36 may be attached (e.g., welded, etc.) directly onto theexterior surface of a respective prong 34.

In some examples, expandable member 18 includes a flexible substrate ormembrane 38 disposed circumferentially around prongs 34 in order to fillin the gaps 35 between adjacent prongs 34. As shown in FIG. 3A, membrane38 may be positioned radially inward of prongs 34 and/or radiallyoutward of prongs 34. Membrane 38 may include, for example, afluid-impermeable membrane, such as a blood impermeable membrane. Forexample, membrane 38 may include a polymer covering configured tocomplete a suction seal (e.g., to help maintain vacuum pressure withinlumen 25 while engaged with clot) and prevent a flow of fluids (e.g.,blood, saline, and the like) between consecutive prongs 34. Membrane 38may also help catheter 10 to block an antegrade blood flow whileinserted within a patient's vasculature, which may reduce or preventemboli from flowing through and/or past the distal opening into lumen 25of catheter 10 during an aspiration procedure. Membrane 38 may beconfigured to stretch or fold to allow for expansion and contraction ofexpandable member 18. In the examples depicted in FIGS. 3B and 3C,membrane 38 has been removed to show the structure of prongs 34.

In some examples, membrane 38 may not extend the entire axial length ofexpandable member 18, for example, may cover only a proximal portion ofprongs 34, terminating proximally of the distal end 34B of prongs 34. Insome examples, membrane 38 is made of ePTFE and is adhered to prongs 34of expandable member 18 with suitable adhesive. In some examples,membrane 38, which may contact a wall of a vessel within a patient'svasculature, may be perforated with perforations or “weep holes.” Theseperforations may facilitate purging the device of air just prior toimplantation. Weep holes may also be provided in the proximal-facingsurface of the membrane, if it beneficial to permit some small seepageof blood past the membrane 38.

For ease of illustration of the structure of the example expandablemembers described herein, membrane 38 is only shown in the example ofexpandable member 18 shown in FIG. 3A. Any expandable member describedherein can include membrane 38 in some examples.

FIGS. 7-8B depict another example expandable member 50, which is anexample of expandable member 18 of catheter 10. Specifically, FIG. 7 isa perspective view of an example expandable member 50, and FIGS. 8A and8B are conceptual diagrams depicting techniques for expanding expandablemember 50 from a contracted configuration (FIG. 8A) to an expandedconfiguration (FIG. 8B). Expandable member 50 may be an example ofexpandable member 18 of FIG. 2A. For example, as with expandable member18, in some examples, expandable member 50 may be mechanically coupledto the structural support member 30 and/or layered between (at least ina proximal portion of the expandable member 50) inner liner 28 and outerjacket 32. For example, expandable member 50 and structural supportmember 30 can be formed independently of one another, and the proximalend of expandable member 50 may be coupled to the distal end ofstructural support member 30 or structural support member 30 andexpandable member 50 can remain unconnected within catheter 10. In someexamples, expandable member 50 and structural support member 30 may bejoined via welding, brazing, soldering, epoxy, mechanical attachmentmechanisms (e.g., hooks) or other suitable technique. In other examples,structural support member 30 and expandable member 50 may be integrallyformed, e.g., have a unibody configuration.

As shown in FIGS. 7-8B, expandable member 50 defines a skeletalframework configured to maintain structural integrity of expandablemember 50 while under a suction force, e.g., during aspiration of aclot. For example, the skeletal framework may include a tubularlattice-like structure composed of a plurality of interconnectedelongated elements, including elongated legs 52, 54 and struts 56. Insome examples, expandable member 50 may be formed (e.g., laser-cut) froma single piece of material, such as a nickel-titanium alloy. In otherexamples, individual elongated elements may be assembled and coupled(e.g., adhered, welded, bonded, etc.) accordingly.

Expandable member 50 includes at least one elongated leg 52 extending inan axial direction (e.g., a longitudinal axis of a particular leg 52 canbe substantially parallel to central longitudinal axis 26 of FIG. 2A).Legs 52 may be referred to herein as “slidable legs 52,” in that theymay be configured to move distally and proximally relative to anotherportion of catheter 10 (e.g., relative to elongated body 12). Forexample, similar to prongs 34 of expandable member 18 of FIGS. 1-6B,expandable member 50 may be mechanically coupled to one or moreactuation members or pull members 36 (FIGS. 8A-8B) configured to apply aproximal tensile force to a proximal end 52A of slidable legs 52,causing slidable legs 52 to move proximally from their natural orresting configuration in which no external pulling forces are applied tothe respective leg 52. Slidable legs 52 may automatically return totheir natural or resting configuration (e.g., may move distally) inresponse to removing the proximal tensile force from the one or morepull members (e.g., due to a natural elasticity of the material ofexpandable member 50), or in some examples, in response to theapplication of a distal tensile force to the respective pull members. Insome examples, expandable member 50 includes a plurality of slidablelegs 52, such as four to six slidable legs 52, disposedcircumferentially around central longitudinal axis 26.

In addition to one or more slidable legs 52, expandable member 50includes a plurality (e.g., two or more) fixed legs 54. For example,expandable member 50 may include as few as two fixed legs 54, or up toas many as double or more of the number of slidable legs 52. In someexamples, expandable member 50 may include the same number of fixed legs54 as slidable legs 52.

Similar to slidable legs 52, each fixed leg 54 may include an elongatedstructure generally extending in an axial direction, e.g., such that alongitudinal axis of a fixed leg 54 approximately parallel to centrallongitudinal axis 26 of elongated body 12. However, unlike slidable legs52, proximal ends 54A of fixed legs 54 may be rigidly coupled toelongated body 12, such that fixed legs 54 are not designed to moveproximally or distally with respect to elongated body 12. In someexamples, slidable legs 52 and fixed legs 54 may be disposedcircumferentially around central longitudinal axis 26 in an alternatingpattern such that each slidable leg 52 is located between two fixed legs54. In some examples, expandable member 50 may include two fixed legs 54located between each pair of adjacent slidable legs 52, such that eachslidable leg 52 includes a fixed leg 54 on either circumferential side.In these examples, immediately adjacent fixed legs 54 may be rigidlycoupled to one another in order to distribute a radially expansive forcearound the circumference of expandable member 50.

Expandable member 50 further includes one or more struts 56 connectingat least one slidable leg 52 to at least one fixed leg 54. Each strut 56includes an elongated body having a first end 56A that is hingedlyconnected to one of slidable legs 52, and a second end 56B that ishingedly connected to one of fixed legs 54, wherein the fixed leg 54 isdirectly adjacent (e.g., not separated by another leg 52 or 54) to theslidable leg 52. In some examples, each strut hinge 58 may be orientedsuch that first end 56A is located distal to the respective second end56B. For example, as shown in FIG. 8A, when expandable member 50 is in acontracted configuration, each strut 56 may be oriented at an angle withrespect to the slidable leg 52 and the fixed leg 54 to which therespective strut is connected. For example, strut 56 may be oriented soas to define a first acute angle 60A between strut 56 and slidable leg52, and a first acute angle 61A between strut 56 and fixed leg 54. Insome examples, while expandable member 50 is in the contractedfiguration, angles 60A and 61A may each be between about 15 degrees and60 degrees, such as about 30 to 45 degrees, or about 35 degrees. In someexamples, angle 60A is 35 degrees and angle 61A is 30 degrees. Forangles greater than about 60 degrees, the expandability of expandablemember 50 may be restricted in some examples. Strut 56 may also beoriented so as to define a first width w between slidable leg 52 andadjacent fixed leg 54 while expandable member 50 is in a contractedconfiguration.

As shown in FIG. 8B, in response to a proximal force (indicated by arrow64) applied to slidable leg 52 via pull member 36, slidable leg 52 maymove proximally relative to fixed legs 54. Accordingly, first end 56A ofstrut 56, which is coupled to slidable leg 52, may also move proximallyrelative to second end 56B of strut 56, which is coupled to fixed leg54. The proximal motion of first end 56A of strut 56 causes strut 56 torotate relative to both slidable leg 52 and fixed leg 54, widening acuteangle 60A (FIG. 8A) into angle 60B (FIG. 8B) and widening acute angle61A (FIG. 8A) into angle 61B (FIG. 8B). In some examples, whileexpandable member 50 is in the expanded configuration shown in FIG. 8B,angles 60B and 61B may each be between about 70 degrees and 90 degrees,such as about 75 degrees.

During the rotational motion of strut 56, strut 56 may apply acircumferential force between slidable leg 52 and fixed leg 54, causingat least distal end 54B of fixed leg 54 and distal end 52B of slidableleg 52 to move away from one another, thereby widening width w (FIG. 8A)into larger width W (FIG. 8B) between slidable leg 52 and fixed leg 54.When this mechanism is actuated at one or more points around thecircumference of expandable member 50, expandable member 50 expandsradially outwards (e.g., away from longitudinal axis 26) into anexpanded configuration in order to provide additional space for thelarger width W between each slidable leg 52 and each adjacent fixed leg54. This expansion mechanism opens mouth 13 at distal end 12B ofelongated body 12 to inner lumen 25, thereby increasing the aspirationpotential of catheter 10. The expansion mechanism also enablescontrolled opening and closing of expandable member 50, potentiallyimproving patient outcomes and care by enabling a clinician to controlthe opening and closing of expandable member 50 to better engage a clotor other material to be aspirated within a blood vessel or other hollowanatomical structure of a patient. In some examples, control circuitry 8of FIGS. 1A and 1B may be configured to control the expansion andcontraction of expandable member 50. For example, control circuitry 8may manipulate slidable legs 52 to cyclically expand and contractexpandable member 50 according to an expansion frequency or othertiming, such as based on a cardiac cycle, a suction frequency, or otherfrequencies as detailed further below.

In some examples, when in an expanded configuration, struts 56 may beoriented approximately perpendicular or transverse to legs 52, 54 (e.g.,angles 60B, 61B may form approximately ninety-degree angles). In otherexamples, angles 60B, 61B may remain acute angles, e.g., due toexpansion tolerances of strut hinges 58.

In some examples, such as the example depicted in FIG. 7, all ofslidable legs 52 and fixed legs 54 include rigid elongated structuresthat are substantially parallel with one another. Accordingly, whenexpanding into an expanded configuration, expandable member 50 mayradially expand by an approximately equivalent distance along its entirelength between proximal ends 52A, 54A, and distal ends 52B, 54B, ofslidable legs 52 and fixed legs 54, respectively. In other examples,such as the example depicted in FIGS. 8A and 8B, either or both ofslidable leg 52 and/or fixed legs 54 may include one or more leg hinges62, enabling the respective leg to bend or flex at various points alongits length, and enabling expandable member 50 to radially expand fartherat some points along its length as compared to other points. Forexample, as shown in FIGS. 8A and 8B, fixed legs 54 each include two leghinges 62, enabling expandable member 50 to radially expand near adistal end 54B of fixed legs 54, while remaining at a fixed radialdistance near a proximal end 54A of fixed legs 54. As shown in FIG. 8A,in some examples, leg hinges 62 may be configured such that, whileexpandable member 50 is in a contracted configuration, a distal end 54Bof legs 54 may be nearer to central longitudinal axis 26 than a proximalend 54A of legs 54 (e.g., width w is smaller near a distal end 54B thannear a proximal end 54A. In these examples, expandable member 50 maydefine a tapered distal tip of catheter 10.

In some examples, such as the example shown in FIG. 7, expandable member50 includes a “ring” of struts 56, wherein each strut 56 constitutes oneof a plurality of struts 56 that extends generally circumferentiallyaround expandable member 50 at a common axial distance along the lengthof legs 52, 54. In some examples, the struts in each ring can belongitudinally aligned along central longitudinal axis 26. FIG. 7depicts an expandable member 50 having four rings of struts 56 evenlyspaced between the proximal ends 52A, 54A and the distal ends 52B, 54B,of the respective legs. FIGS. 8A and 8B depict an expandable member 50having two rings of struts 56. In other examples, however, expandablemember 50 can include any suitable number of rings of struts 56, suchas, but not limited to, one, three, four, or more. In some examples,different struts 56 may include elongated structures having differentlengths. For example, a first ring of struts 56 that is located moredistally along expandable member 50 may include struts 56 that arelonger than struts of a second ring of struts that is proximal to thefirst ring of struts. This configuration may enable a wider expansionnear a distal end of expandable member 50 than near a proximal end,forming a conical shape of expandable member 50 when in an expandedconfiguration.

In some examples, struts 56 may not be longitudinally aligned. Forexample, expandable member 50 may include a spiral-type pattern ofstruts 56 that both wraps circumferentially around expandable member 50,and also advances distally from proximal ends 52A, 54A, toward distalends 52B, 54B of legs 52, 54, respectively. In these examples, thestruts 56 that define the spiral-type pattern may not be longitudinallyaligned with each other.

In some examples, expandable member 50 may include one or morecurvilinear elements defining a distal rim 66. Rim 66 may include one ormore sections of a generally circular shape (or any shape defined by across-sectional area of expandable member 50) with each portion affixedto a distal end 52B, 54B of one of legs 52, 54, respectively. In someexamples, while in a contracted configuration, adjacent rim portions 66may contact or nearly contact one another, so as to define a completecircular rim. While in an expanded configuration, expandable member 50may define a gap between respective rim portions 66.

In some examples, struts 56 may be substantially linear (e.g., linear orlinear within manufacturing tolerances). In other examples, such asshown in FIG. 7, struts 56 may be curvilinear so as to conform to acircumference of expandable member 50 when expandable member 50 is in acontracted configuration.

Struts 56 may be coupled to legs 52, 54 via strut hinges 58, which arejoints that are configured to enable some relative movement between astrut 56 and respective legs 52, 54. Strut hinges 58 located at aconnection point between each of legs 52, 54 and struts 56 may reduce anamount of mechanical stress located at these points and enable expansionof expandable member 50 without the use of significant force and/orwithout adverse effects to the structural integrity of the connectionbetween struts 56 and legs 52, 54. In some examples, as shown in FIGS.7-8B, strut hinges 58 may include curved (e.g., C-shaped) extensions ofstruts 56 (e.g., having a same thickness or cross-sectional area asstruts 56), wherein the C-shape is configured to widen or narrow inresponse to a force applied to its ends via strut 56 and the respectiveleg 52, 54 to which strut 56 is coupled. In other examples, expandablemember 50 may include any appropriate hinge mechanism, such as pin-typehinges typically used with door frames, spring hinges, butterfly-typehinges, etc.

In some examples, rather than expanding in response to a proximal motionof slidable legs 52, expandable member 50 may be configured to contractin response to a proximal motion of slidable legs 52. For example, insome examples, a default (e.g., heat-set) configuration of expandablemember 50 may be an expanded configuration. In an opposite mechanism tothat described above, a proximal motion of slidable legs 52 (e.g., viapull members 36) may cause struts 56 to rotate to become less transverseto legs 52, 54, applying an inward radial force to legs 52, 54, andcausing expandable member 50 to collapse into a contractedconfiguration. In some examples, expandable member 50 may include bothmechanisms. For example, a proximal motion of slidable legs 52 may causeexpandable member to initially expand from the contracted configurationinto the expanded configuration (e.g., as struts 56 rotate toward atransverse orientation), and then a continued proximal motion ofslidable legs 52 may cause expandable member 50 to collapse back intothe contracted configuration (e.g., as struts 56 rotate past thetransverse orientation). A distal motion of slidable legs 52 (e.g., viapull members 36) may enable this process to run in reverse.

Although depicted in separate figures, the leg-and-strut mechanisms ofFIGS. 7-8B may be used in combination with the flexible prong mechanismsof FIGS. 1-6B, such as within a common expandable member of a catheter10. For example, an expandable member of a catheter may include at leastone elongated structure that functions both as a flexible prong 34 aswell as a leg 52, 54. In other examples, an expandable member mayinclude both leg-and-strut mechanisms and flexible-prong mechanisms thatare mechanically distinct but work in tandem to enable an expansion ofthe expandable member.

As detailed above with respect to expandable member 18, expandablemember 50 may similarly include a flexible membrane 38 (not shown)positioned radially inward of legs 52, 54 and/or radially outward oflegs 52, 54. The description of flexible membrane 38 provided withrespect to expandable member 18 also applies to expandable member 50.

In some examples of catheter 10, expandable member 18 includes amagnetic material configured to enable the transition of expandablemember 18 between an expanded configuration and a contractedconfiguration. For example, expandable member 18 may includestrategically located and oriented regions of magnetic materialconfigured to control or guide a folding of expandable member 18 into acontracted configuration and/or an unfolding of expandable member 18into an expanded configuration, in response to user actuation of anelectromagnetic controller mechanism. In any of the examples of anexpandable member 18 including a magnetic material and in which themagnetic force (e.g., attractive or repulsive) of a magnetic materialare configured to hold the expandable member in an expanded state, themagnetic forces may be sufficient to hold the expandable material in theexpanded state even in the presence of a suction force applied bysuction source 4 (FIG. 1A).

FIGS. 9A-9D depict an example expandable member 68 of catheter 10 (FIG.2A) that includes a magnetic material. Specifically, FIG. 9A is aconceptual cross-sectional side view of expandable member 68 in anexpanded configuration; FIG. 9B is a conceptual end view of expandablemember 68 in an expanded configuration; FIG. 9C is a conceptualcross-sectional side view of expandable member 68 in a contractedconfiguration; and FIG. 9D is a conceptual end view of expandable member68 in a contracted configuration. Expandable member 68 is an example ofexpandable member 18 of FIG. 2A. For example, expandable member 68 maybe mechanically coupled to structural support member 30, inner liner 28,and/or outer jacket 32 using any of the techniques described withreference to expandable member 18, above.

Expandable member 68 is configured to transition between an expandedconfiguration (FIGS. 9A and 9B) and a contracted configuration (FIGS. 9Cand 9D) at least in response to magnetic attraction and/or repulsion.For example, expandable member 68 may expand and/or contract in responseto application, removal, and/or activation of electromagnetic forcesinternal or external to expandable member 68.

In the example shown in FIGS. 9A-9D, expandable member 68 includes abody structure 72 and a magnetic material 78. In some examples, bodystructure 72 includes a flexible polymer, e.g., similar to membrane 38as described above. The polymer may be a single piece of material or oneor more discrete polymeric sections 76 connected directly together orinterposed with magnetic material 78. For example, body structure 72 caninclude a plurality of discrete polymer sections 76 arranged inalternating fashion with magnetic material 78 in a circumferentialand/or axial direction (e.g., in a direction along longitudinal axis 26of elongated body 12).

Body structure 72 is depicted in FIGS. 9A and 9B as having a tubularstructure (e.g., having a circular cross-sectional area) while in anexpanded configuration. In other examples, however, body structure 72can have another suitable shape having any suitable cross-sectionalshape, such as, but not limited to, a non-circular closed geometricalshape.

Magnetic material 78 is coupled to or embedded within body structure 72.In some examples, magnetic material 78 includes a permanent magneticmaterial, such as a ferromagnetic material that is magnetized to produceits own magnetic field. In other examples, magnetic material 78 mayinclude a ferromagnetic material that responds to an external magneticfield, but that does not generate one on its own.

Magnetic material 78 can have any suitable arrangement within expandablemember 68 and relative to body structure 72. In some examples, magneticmaterial 78 is arranged in one or more discrete sections, such thatthere are some discrete regions of body structure 72 without magneticmaterial 78 and, for example, only polymer sections 76 or othernon-magnetic structures. For example, the discrete sections of magneticmaterial may include longitudinal strips 79 oriented axially along bodystructure 72 (as shown in FIGS. 9A and 9B), one or more ring-shapedregions oriented partially or fully circumferentially around bodystructure 72, or other discrete shapes within body structure 72 orcombinations thereof to define a predetermined pattern of magneticareas. The discrete sections of magnetic material 78 may include one ormore relatively larger, cohesive units of a solid magnetic material,either coupled to or embedded within body structure 72. In otherexamples, the discrete sections of magnetic material 78 can include apolymer substrate (e.g., a polymer of body structure 72) embedded withmagnetic material 78.

In any of the examples of expandable members having magnetic materialsdescribed herein, the sections of the expandable member having themagnetic material can be formed separately from and attached to thepolymer or other expandable membrane of the body structure, can beformed integrally with the polymer, or can be three-dimensionallyprinted onto a polymer. For example, magnetic material 78 can bethree-dimensionally printed onto a polymer in a desired pattern (e.g.,strips 79 or other discrete sections) in the presence of a magnetic toimpart certain magnetic orientations) to the resulting sections ofmagnetic material.

In the example depicted in FIGS. 9A-9D, expandable member 68 includes abody structure 72 defining alternating strips of polymeric material 76and magnetic strips 79 of a permanent magnetic material 78. Eachmagnetic strip 79 may extend axially (e.g., parallel to centrallongitudinal axis 26) and may be distributed circumferentially aroundbody structure 72. In some examples, each magnetic strip 79 may distallyextend from a proximal end of expandable member 68 to mouth 13 at distalend 12B of elongated body 12. In other examples, one or more of themagnetic strips may not extend the full axial length of expandablemember 68. For example, some or all of the magnetic strips may begindistally of a proximal end of expandable member 68 and/or terminateproximally from distal end 12B. In some examples, one or more of themagnetic strips 79 may include two or more separate magnetic strips thatare circumferentially aligned with one another and axially displacedfrom one another. The example depicted in FIGS. 9A and 9B depicts fivemagnetic strips 79, however, expandable member 68 may include any numberof magnetic strips 79, each strip 79 having virtually any suitablewidth, measured in a circumferential direction along an outer perimeterof expandable member 68.

In some examples, but not all examples, all of magnetic strips 79 may beoriented such that their magnetic fields all align in a commondirection. For example, magnetic strips 79 may be permanent magnetsoriented such that their magnetic fields are parallel within a regioninternal to expandable member 68, for example, within inner lumen 25. Insome examples, as indicated by magnetic-field directional indicators 86,the magnetic fields of permanent magnetic strips 79 all point in adistal direction within lumen 25, for example, in a direction towardmouth 13 at distal end 12B of elongated body 12. In other examples,magnetic strips 79 may be oriented such that their magnetic fields allpoint in a proximal direction within lumen 25. In such examples, themagnetic field of each permanent magnetic strip 79 naturallymagnetically repels the magnetic fields of all of the other permanentmagnetic strips 79. When no external magnetic field is applied toexpandable member 68, the mutual magnetic repulsive force between eachpair of permanent magnetic strips 79 imparts an outward radial forceonto expandable member 68, holding expandable member 68 in the expandedconfiguration shown in FIGS. 9A and 9B.

In examples in which catheter 10 includes expandable member 68 includinga magnetic material configured to expand radially outward or contractradially inward in response to a magnetic force proximate expandablemember 68, an aspiration system including catheter 10 can furtherinclude a magnetic device 74 configured to generate the magnetic force(e.g., an external magnetic field). Magnetic device 74 is configured toenable a user or control circuitry 8 to control (e.g., actuate) theexpansion and/or contraction of expandable member 68. For example,control circuitry 8 may be configured to cyclically expand and contractexpandable member 68 at an expansion frequency or other timing, asdetailed further below. Magnetic device 74 may be fixed relative toexpandable member 68, or may be movable relative to expandable member68. In some examples, magnetic device 74 distinct from (e.g., physicallyseparate from and movable relative to) elongated body 12, while in otherexamples, magnetic device 74 is mechanically connected to elongated body12 and/or expandable member 68.

In examples in which magnetic device 74 is connected to elongated body12 and/or expandable member 68, magnetic device 74 may be fixed relativeto expandable member 68 in a manner that does not permit movement ofmagnetic device 74 relative to expandable member 68, or maybe connectedto catheter 10 in a manner that enables some relative movement ofmagnetic device 74 and expandable member 68. In some examples, magneticdevice 74 may be external to elongated body 12, while in other examples,magnetic device 74 is positioned internal to elongated body 12, such aswithin lumen 22 or another lumen, e.g., parallel to lumen 22.

In the example of FIGS. 9A-9D, magnetic device 74 includes anelectromagnet, such as a solenoid configured to generate a magneticfield when energy is applied to the solenoid. For example, a rod 80 maybe wrapped with a coil of conductive wire 82, so as to create anelectromagnet. Rod 80 can be, for example, a guidewire or anotherelongated structure that is configured to move relative to catheter 10.In these examples, rod 80 may also serve as a guide member thatfacilitates navigation of catheter 10 through vasculature of a patient.Rod 80 can be, for example, a nitinol wire or a stainless steel wire. Inother examples, rod 80 is connected to catheter 10 and a separate guidemember may be used to navigate catheter 10 through vasculature. Wire 82may include any suitable electrically conductive material, such as, butnot limited to, gold or copper. In some examples, a portion ofconductive wire 82 (e.g., any portion that is not coiled around rod 80)may extend through the entire length of inner lumen 22 of elongated body12 and into lumen 23 of handle 14 (FIG. 2A) and electrically connectedto a power source. In such examples, aspiration system 2A (FIG. 1A)includes a battery or other source of electrical current to pass throughconductive wire 82, activating the electromagnetic properties ofmagnetic device 74, for example, generating a magnetic field withinand/or around expandable member 68.

In some examples in accordance with this disclosure, magnetic device 74may enable expandable member 68 to convert between an expandedconfiguration (FIGS. 9A and 9B) and a collapsed or contractedconfiguration (FIGS. 9C and 9D). For example, while magnetic device 74is deactivated (e.g., no electric current is passing through conductivewire 82), expandable member 68 may be in an expanded configuration, asdescribed above.

As illustrated in FIG. 9D, when magnetic device 74 is activated (viaelectrical energy) while magnetic device 74 is within lumen 25 oroutside of expandable member 70 and longitudinally adjacent to lumen 25,such as by a user actuating user-input device 20 (FIG. 2A), magneticfield 88 is generated around magnetic device 74, oriented or aligned inan opposing direction (e.g., a proximal direction, from the perspectiveof FIG. 9D) from the magnetic fields 86 of magnetic strips 79.Accordingly, magnetic field 88 may attract the magnetic fields 86 of themagnetic strips 79 of body structure 72. Because the attractive forcebetween magnetic device 74 and magnetic strips 79 is configured to bestronger than the mutual repulsive force between each pair of magneticstrips 79 when magnetic device 74 is activated, activated magneticdevice 74 pulls the magnetic material 78 of magnetic strips 79 towardmagnetic device 74, causing the outer circumference of body structure 72to contract inward toward magnetic device 74 (indicated by directionalarrows 84 in FIG. 9C), collapsing expandable member 68 into a contractedconfiguration.

In other examples, instead of or in addition to discrete sections ofmagnetic material, such as longitudinal strips 79, an expandable memberof catheter can include a plurality of relatively smaller particles ofmagnetic material, such as iron filings or another magnetic material,embedded within a polymer or other substrate of an expandable bodystructure. The magnetic particles may either include particles of apermanent magnetic material, or may include a ferromagnetic materialthat has been magnetized to become a permanent magnet. The magneticmaterial in each section may be oriented such that the section defines arespective magnetic domain where there is a substantially uniformmagnetic field (e.g., uniform or functionally uniform).

FIGS. 10A and 10B depict another example expandable member 70 ofcatheter 10 (FIG. 2A) that includes a magnetic material. Specifically,FIG. 10A is a conceptual cross-sectional side view of expandable member70 in an expanded configuration, and FIG. 10B is a conceptual end viewof expandable member 70 in an expanded configuration.

Similar to expandable member 68 of FIGS. 9A-9D, expandable member 70 isconfigured to transition between an expanded configuration (FIGS. 10Aand 10B) and a contracted configuration at least in response to magneticattraction and/or repulsion. For example, expandable member 70 mayexpand and/or contract in response to application, removal, and/oractivation of electromagnetic forces internal or external to expandablemember 70. The contracted configuration of expandable member 70 may looklike the contacted configuration of expandable member 68, e.g., shown inFIGS. 9C and 9D.

In the example shown in FIGS. 10A and 10B, expandable member 70 includesa body structure 73. In some examples, body structure 73 includes aflexible polymer, e.g., similar to membrane 38 and/or body structure 72described above. The polymer may be embedded, or infused with magneticmaterial 78. In some examples, body structure 73 consists essentially ofa single piece of polymer including magnetic material 78. In otherexamples, however, body structure 73 can include a plurality of piecesof polymer material mechanically connected together, e.g., via anadhesive, welding, thermal bonding, or the like.

Body structure 73 is depicted in FIGS. 10A and 10B as having a tubularstructure (e.g., having a circular cross-sectional area) while in anexpanded configuration. In other examples, however, body structure 73can have another suitable shape having any suitable cross-sectionalshape, such as, but not limited to, a non-circular closed geometricalshape.

Magnetic material 78 is coupled to or embedded within body structure 73.In some examples, magnetic material 78 includes a permanent magneticmaterial, such as a ferromagnetic material that is magnetized to produceits own magnetic field. In other examples, magnetic material 78 mayinclude a ferromagnetic material that responds to an external magneticfield, but that does not generate one on its own.

Magnetic material 78 can have any suitable arrangement within expandablemember 70 and relative to body structure 73. In some examples, magneticmaterial 78 may include a plurality of relatively smaller particles ofmagnetic material, such as iron filings or another magnetic material,embedded within polymer 76 of body structure 73. The magnetic particlesmay either include particles of a permanent magnetic material, or mayinclude a ferromagnetic material that has been magnetized to become apermanent magnet. The magnetic material in each section may be orientedsuch that the section defines a respective magnetic domain. In someexamples, all of the magnetic domains of magnetic material 78 ofexpandable member 70 point in a common direction (e.g., a proximaldirection or a distal direction) in the region interior to bodystructure 73.

As shown in FIGS. 10A and 10B, in some examples, magnetic material 78may be approximately evenly distributed throughout body structure 73.For example, magnetic material 78 may include a plurality of relativelysmaller particles of magnetic material distributed substantiallyuniformly (e.g., uniformly but for manufacturing tolerances) throughoutbody structure 73. In any of these examples, all of the individualmagnetic particles within body structure 73 may be oriented in oraligned to a common direction, such that the magnetic fields of theindividual particles may combine to approximate a common magnetic domainwithin body structure 72. For example, as indicated by magnetic-fielddirectional indicators 86, the magnetic fields of the magnetic particlesof magnetic material 78 all point in a distal direction within lumen 25,for example, in a direction toward mouth 13 at the distal end 12B ofelongated body 12. In other examples, magnetic particles of magneticmaterial 78 may be oriented such that their magnetic fields all point ina proximal direction within lumen 25. In all such examples, the magneticfield of each magnetic particle naturally magnetically repels themagnetic fields of all of the other permanent magnetic particles. Themutual magnetic repulsive force between every pair of permanent magneticparticles imparts an outward radial force onto expandable member 70,holding expandable member 70 in the expanded configuration shown inFIGS. 10A and 10B.

Similar to the example depicted in FIGS. 9C and 9D, expandable member 70is configured such that when no external magnetic field is applied toexpandable member 70, e.g., by magnetic device 74 or another device,expandable member 70 maintains its expanded configuration. When a userintroduces (e.g., inserts and/or activates) magnetic device 74 intolumen 25 or outside of lumen 25 (e.g., along an outer surface ofexpandable member 70), magnetic field 88 of magnetic device 74magnetically attracts the magnetic field 86 of the magnetic material 78of body structure 73. Because the attractive force between magneticdevice 74 and magnetic material 78 is configured to be stronger than themutual repulsive force between each pair of magnetic particles,activated magnetic device 74 pulls the magnetic material 78 of bodystructure 73 toward magnetic device 74, causing the outer circumferenceof expandable member 70 to contract inward into a contractedconfiguration.

In another example of expandable member 70, body structure 73 includesan approximately even distribution of magnetic material 78, such asmagnetic particles, however the magnetic material 78 is arranged intodiscrete sections of common magnetic domains. The magnetic domains maybe oriented and arranged in a strategic pattern such that some of themagnetic domains magnetically attract other ones of the magnetic domainsaround the circumference of body structure 73. In the absence of anyexternal magnetic fields or other external forces, the magneticattractions between various magnetic domains of body structure 73 causeexpandable member 70 to collapse into the contracted configuration,similar to the contracted configuration of expandable member 68 shown inFIGS. 9C and 9D. When a user introduces (e.g., inserts and/or activates)magnetic device 74 into lumen 25 or outside of lumen 25 (e.g., along anouter surface of expandable member 70), magnetic field 88 of magneticdevice 74 magnetically repels the magnetic domains of body structure 73having similarly oriented magnetic fields, causing expandable member 70to expand outward into the expanded configuration shown in FIGS. 10A and10B.

FIGS. 11A and 11B depict another example expandable member 90 thatincludes a magnetic material 78 and is configured to expand and contractusing the magnetic material 78. Expandable member 90 may be an exampleof expandable member 68 of FIGS. 9A-9D. Specifically, FIG. 11A is aconceptual end view of an example of expandable member 90 in acontracted configuration, and FIG. 11B is a conceptual end view of theexample expandable member 90 of FIG. 11A in an expanded configuration.FIGS. 11A and 11B, as well as the other figures herein, may not be drawnto scale; the positions, sizes, and/or orientations of one or morecomponents of the figures may be altered for purposes of clarifying andillustrating the techniques of this disclosure.

Unlike the example of expandable member 68 shown in FIGS. 9A-9D, inwhich all of magnetic strips 79 of body structure 72 are oriented suchthat their magnetic fields 86 are aligned in a common direction,expandable member 90 of FIGS. 11A and 11B includes body structure 75having magnetic strips 81A, 81B (collectively, “magnetic strips 81”)oriented such that two or more of the magnetic strips 81 have magneticfields that are misaligned or anti-aligned (e.g., anti-parallel), in astrategic pattern. For example, as shown in FIG. 11A, expandable member90 includes a first plurality of magnetic strips 81A with magneticfields commonly aligned in a first direction (e.g., parallel to oneanother), and a second plurality of magnetic strips 81B with magneticfields commonly aligned in a second direction (e.g., parallel to oneanother). The first direction may be directionally opposite to (e.g.,oriented 180 degrees from) the second direction.

Magnetic strips 81 can each be discrete sections of magnetic material,whether in in the form of sections of substantially magnetic material(e.g., as described with reference to longitudinal strips 79 shown inFIGS. 9A-9D) or a polymer embedded with a magnetic material. Magneticstrips 81 are separated from each other by sections of nonmagneticmaterial, e.g., sections of polymer 76 not embedded with a magneticmaterial.

As shown in FIGS. 11A and 11B, magnetic strips 81A each generate amagnetic field pointing in a generally distal direction (e.g., adirection toward a distal end of catheter 10) in the region surrounding(e.g., external to) the strips. Magnetic strips 81B each generate amagnetic field pointing in a generally proximal direction (e.g., adirection toward a proximal end of catheter 10) in the regionsurrounding (e.g., external to) the strips. Accordingly, distal magneticstrips 81A naturally magnetically attract proximal magnetic strips 81B.

In some examples, expandable member 90 defines one or more folds 89.Folds 89 may be formed into the material of body structure 75, which maybe an example of body structure 72, as described above. For example,folds 89 may be heat-set, cut, or sewn, or otherwise permanentlyintegrated into the material of body structure 75, such as intopolymeric material 76. Folds 89 may be configured to guide a bending ofthe material of body structure 75 along a desired direction or into adesired configuration in response to an applied force, e.g., frommagnetic strips 81A, 81B repelling each other or attracting each other.In other examples, however, expandable member 90 does not have anypredefined folds 89 and is configured to collapse more organically intothe contracted configuration.

In some examples, the arrangement of magnetic strips 81A, 81B around thecircumference of body structure 75 relative to folds 89 enablesexpandable member 90 to automatically fold into a contractedconfiguration while magnetic device 74 is not generating a magneticfield that influences the magnetization of magnetic strips 81A, 81B,e.g., is deactivated and/or removed from lumen 25. For example, as shownin FIGS. 11A and 11B, an arrangement may include groups of threemagnetic strips 81, each group including one magnetic strip 81B locatedbetween one magnetic strip 81A and one magnetic strip 81B. The exampledepicted in FIGS. 11A and 11B includes four groups of magnetic strips,however, expandable member 90 may include any number of groups ofmagnetic strips, as well as other arrangements (e.g., number and/orsequence) of magnetic strips 81 in each group. In response to themagnetic attractions and repulsions between strips 81 within each group,and expandable member 90 may bend along pre-defined folds 89 such thatthe outer two magnetic strips of each group move toward each other underthe force of magnetic attraction, and the middle strip of each groupmoves radially inward, collapsing expandable member 70 into thecontracted configuration shown in FIG. 11A.

When a user activates magnetic device 74, such as by actuatinguser-input device 20 (FIG. 2A) or other user input device, magneticdevice 74 generates a proximally oriented magnetic field (indicated byfield indicators 88) in the immediate region external to magnetic device74 that magnetically attracts distal magnetic strips 81A andmagnetically repels proximal magnetic strips 81B. Because expandablemember 90 includes more proximal magnetic strips 81B than distalmagnetic strips 81A (e.g., twice as many proximal strips 81B as distalstrips 81A in each group of strips 81), the net repulsive force betweenmagnetic device 74 and proximal magnetic strips 81B may be stronger thanthe net attractive force between magnetic device 74 and distal magneticstrips 81A. Additionally or alternatively, due to a relatively largestrength of the proximal magnetic field of magnetic device 74, the netrepulsive force between magnetic device 74 and proximal magnetic strips81B is stronger than the attractive force between the outer two magneticstrips of each group of magnetic strips. For at least one of these tworeasons, activated magnetic device 74 magnetically repels proximalmagnetic strips 81B away from magnetic device 74, such that bodystructure 75 unfolds, causing expandable member 90 to expand into theexpanded configuration shown in FIG. 11B. Expandable member 90 maymaintain the expanded configuration while magnetic device 74 isactivated proximate expandable member 90 (e.g., close enough for themagnetic field generated by magnetic device 74 to attract magneticstrips 81B).

FIGS. 12A and 12B depict another example expandable member 105, whichmay be an example of expandable member 70 of FIGS. 10A and 10B.Specifically, FIG. 12A is a conceptual end view of an example ofexpandable member 105 in an expanded configuration, and FIG. 12B is aconceptual end view of the example expandable member 105 of FIG. 12A ina contracted configuration.

Unlike example expandable members 68, 70, and 90, which include apermanent magnetic material 78 defining one or more permanent magneticdomains, expandable member 105 includes a ferromagnetic material 83 thatis configured to react to an external magnetic field, but does notinherently generate a magnetic field of its own. For example, expandablemember 105 includes body structure 77, which may be an example of bodystructures 72, 73, and/or 75, as described above. Body structure 77includes a ferromagnetic material 83, such as embedded ferromagneticparticles. For example, ferromagnetic material 83 may include such asiron particles or another ferromagnetic material, coupled to or embeddedwithin the material of body structure 77, such as a polymeric material.

Expandable member 105 includes self-expanding structure 103, referred toherein as a self-expanding tube herein, although self-expandingstructure 103 can include another shape in other examples. In someexamples, self-expanding tube 103 includes a flexible tubular memberconfigured to remain in an expanded configuration in the absence of anyapplied forces, due to mechanical properties of its composing material.For example, self-expanding tube 103 may self-expand due to an intrinsicmaterial spring mechanism, similar to a self-expanding stent.Self-expanding tube 103 may be located within the inner lumen 25 ofexpandable member 105, e.g., for example, internal to, and concentricwith, body structure 77. Self-expanding tube 103 may fit snugly ortightly within body structure 77 such that its intrinsic expansionmechanism applies an outward radial force onto the interior surface ofbody structure 77. The outward radial force from self-expanding tube 103may hold body structure 77 in an expanded configuration, as shown inFIG. 12A.

As shown in FIG. 12B, a user may introduce a magnet 107 into the innerlumen 25 of expandable member 105. Magnet 107 may be an example ofmagnetic device 74 described above. In some examples, magnet 107 mayinclude a permanent magnet rigidly fixed to the end of an elongatedstructure, such as a guidewire. In other examples, magnet 107 mayinclude an electromagnet, such as an electromagnetic solenoid asdescribed above. In some examples, the user may manually feed magnet 107distally through the lumen 22 of elongated body 12 and into lumen 25 ofexpandable member 105. In other examples, the user may actuateuser-input device 20 (FIG. 2A) to distally insert magnet 107 into, andproximally retract magnet 107 from, lumen 25 of expandable member 105.When magnet 107 is positioned in lumen 25 of expandable member 105,magnet 107 magnetizes the ferromagnetic material 83 of body structure77, magnetically attracting material 83 toward magnet 107. The magneticattractive force pulls the circumference of body structure 77 radiallyinward, forcing expandable member 105 to collapse, as shown in FIG. 12B.For example, the magnetic attraction between magnet 107 and theferromagnetic material 83 of body structure 77 may be stronger than theoutward radial pressure from self-expanding tube 103, overcoming theoutward radial pressure from self-expanding tube 103 and collapsingexpandable member 105 into the contracted configuration shown in FIG.12B.

FIGS. 13A and 13B depict another example expandable member 110, whichmay be an example of expandable member 105 of FIGS. 12A and 12B.Specifically, FIG. 13A is a conceptual end view of an example ofexpandable member 110 in a contracted configuration, and FIG. 13B is aconceptual end view of the example expandable member 110 of FIG. 13A inan expanded configuration.

Unlike example expandable member 105 of FIGS. 12A and 12B, in which bodystructure 77 includes (non-permanent) ferromagnetic particles,expandable member 110 of FIGS. 13A and 13B includes body structure 85having embedded permanent magnetic particles, similar to exampleexpandable member 70 of FIGS. 10A and 10B. Permanent magnetic particlesmay be distributed around the entire circumference of body structure 85,which may be an example of body structures 72, 73, 75, and/or 77. Insome examples, the permanent magnetic particles of body structure 85 arecommonly oriented such that their intrinsic magnetic fields all repeleach other, holding body structure 85 in an expanded configuration inthe absence of any external forces.

Expandable member 110 includes self-contracting tube 112.Self-contracting tube 112 may be an example of self-expanding tube 103of expandable member 105. For example, the intrinsic spring propertiesof the materials of both self-expanding tube 103 and self-contractingtube 112 may be configured to resist both compressive and expansiveforces, and remain in a generally tubular structure in the absence ofexternal forces. For example, self-contracting tube 112 mayself-contract due to an intrinsic material spring mechanism.Self-contracting tube 112 may be located external to, and concentricwith, body structure 85, such that body structure 85 is located withinan inner lumen of self-contracting tube 112. Self-contracting tube 112may fit snugly or tightly around body structure 85 such that itsinternal contraction mechanism applies an inward radial force to theexterior surface of body structure 85. For example, the inner diameterof self-contracting tube 112 may be smaller than the outer diameter ofbody structure 85, such that the inward radial force fromself-contracting tube 112 may hold body structure 85 in a contractedconfiguration, as shown in FIG. 13A. For example, the inward radialforce from self-contracting tube 112 may be stronger than the outwardradial force of magnetic repulsion intrinsic to the permanent magneticmaterial of body structure 85, such that self-contracting tube 112causes body structure 85 to partially or fully collapse into thecontracted configuration of FIG. 13A.

As shown in FIG. 13B, a user may introduce a magnet 107 into the innerlumen 25 of expandable member 110. In some examples, magnet 107 mayinclude a permanent magnet rigidly fixed to the end of an elongatedstructure, such as a guidewire. In other examples, magnet 107 mayinclude an electromagnet, such as an electromagnetic solenoid asdescribed above. In some examples, the user may manually feed magnet 107distally through the lumen 22 of elongated body 12 and into lumen 25 ofexpandable member 110. In other examples, the user may actuateuser-input device 20 (FIG. 2A) to distally insert magnet 107 into, andproximally retract magnet 107 from, lumen 25 of expandable member 110.

Magnet 107 may generate a magnetic field oriented in the same directionas the magnetic field of the permanent magnetic material of bodystructure 85, such that magnet 107 magnetically repels body structure 85upon entering lumen 25 of expandable member 110. The magnetic repulsionforce pushes the circumference of body structure 85 radially outward,forcing expandable member 110 to expand. For example, the magneticrepulsion between magnet 107 and the magnetic material of body structure85 is stronger than the inward radial pressure from self-contractingtube 112, overcoming the inward radial pressure from self-contractingtube 112 and expanding expandable member 110 into the expandedconfiguration shown in FIG. 13B.

Catheters described herein may be formed using any suitable techniqueand can be used in any suitable medical procedure. FIGS. 14 and 15describe example techniques for making and using, respectively, thecatheters described herein. The techniques of FIGS. 14 and 15 aredescribed with reference to the various aspects of aspiration system 4Aof FIG. 1A and catheter 10 of FIGS. 1A-2B for illustrative purposes,however, such descriptions are not intended to be limiting. Thetechnique of FIG. 14 may be used to form other catheters, or catheter 10of FIGS. 1A-2B may be formed using techniques other than those describedwith reference to FIG. 14. Similarly, the technique of FIG. 15 may beused with other aspiration systems (e.g., aspiration system 2B of FIG.1B) and/or catheters, or aspiration system 2A and/or catheter 10 ofFIGS. 1A-2B may be used using techniques other than those described withreference to FIG. 15.

FIG. 14 is a flow diagram of an example method of forming catheter 10.The technique of FIG. 14 includes positioning structural support member30 over inner liner 28 (140). In some examples, inner liner 28 is atubular body and is placed on a mandrel prior to structural supportmember 30 being positioned over inner liner 28. Inner liner 28 may befabricated using any suitable technique, such as by extrusion. In someexamples, after positioning inner liner 28 over the mandrel, inner liner28 may be heat shrunk onto the mandrel such that inner liner 28 conformsto the outer surface of the mandrel and acquires the profile of themandrel. In other examples, however, heat shrinking may not benecessary. For example, in addition to, or instead of, heat shrinking,inner liner 28 may be longitudinally stretched over the mandrel in orderto substantially conform to the outer surface of the mandrel.

Once inner liner 28 is positioned on the mandrel, structural supportmember 30 (e.g., a coil, a braid, or combinations thereof) may bepositioned over inner liner 28 (140). For example, structural supportmember 30 may include one or more wire elements (e.g., flat wires,flat-round wires, or round wires) coiled or woven over inner liner 28,or pre-coiled or pre-woven and subsequently positioned over inner liner28. Next, expandable member 18 may be positioned relative to inner liner28 (e.g., over a portion of inner liner 28 or distal to inner liner 28)and structural support member 30 (142). In some examples, expandablemember 18 is coupled to structural support member 30. For example, whereexpandable member 18 and structural support member 30 are each formedindependently of one another, the proximal end of expandable member 18may be joined to the distal end of structural support member 30 viawelding, brazing, soldering, epoxy, mechanical hooks, or other suitabletechniques. In other example, expandable member 18 may not be directlyconnected to structural support member 30 and may be held in placerelative to each other via inner liner 28 and outer jacket 32.

In other examples, structural support member 30 and expandable member 18may be integrally formed such that additional coupling is not necessary.For example, catheter 10 may include a hypotube that is cut to form allor a portion of structural support member 30 and expandable member 18such that the two components are integrally formed from the samehypotube. The hypotube may then be stretched and positioned over innerliner 28. In other examples, structural support member 30 and expandablemember 18 may both be formed using metal wires wherein structuralsupport member 30 and expandable member 18 represent differentstructures (e.g., coil vs weave) formed by the wires.

In some examples, the structural configuration of structural supportmember 30 and/or expandable member 18 may be at least partially definedprior to being positioned over inner liner 28. For example, a shapememory wire (e.g., Nitinol alloy) or other structure of an otherwiseheat-settable metal, alloy, or polymer base may be formed over adifferent mandrel where the structure is heat set to define a desiredshape of structural support member 30 and/or expandable member 18. Afterbeing heat set, structural support member 30 and/or expandable member 18may then be subsequently removed from the mandrel, and then repositionedover inner liner 28.

In some examples, defining some or all of the structural characteristicsof structural support member 30 and/or expandable member 18 prior topositioning the structure over inner liner 28 may help control thestructural characteristics of structural support member 30 and/orexpandable member 18 (e.g., gap spacings, pitch, expansioncharacteristics, or the like), as well as control product consistencyand uniformity of structural support member 30 and/or expandable member18 for use in multiple catheters. In addition, shape-setting of themetal structures on a separate, heat-resistant mandrel enables theconstruction of the elongated body 12 without damaging inner liner 28.

Structural support member 30 and expandable member 18, where applicable,may be secured in place relative to inner liner 28 using any suitabletechnique. For example, structural support member 30 may be adhered toinner liner 28. In some examples, an adhesive may be positioned overinner liner 28 prior to positioning structural support member 30 overinner liner 28. In addition to, or instead of, an adhesive, outer jacket32 may be used to secure portions of structural support member 30 andexpandable member 18 to inner liner 28.

The technique of FIG. 14 also includes positioning outer jacket 32 overinner liner 28 and structural support member 30 (144). For example, theone or more sections forming outer jacket 32 may be independently formed(e.g., extruded) and slid over inner liner 28, structural support member30, and, in some examples, expandable member 18 in the desiredarrangement. Outer jacket 32 may be connected to inner liner 28 usingany suitable technique. For example, outer jacket 32 may be heat shrunkover inner liner 28. A suitable technique for connecting outer jacket 32to inner liner 28 may include, heating outer jacket 32 while outerjacket 32 is in heat shrink tubing enough to cause the material of outerjacket 32 to melt, then reflow the material of outer jacket 32. In someexamples, the heat shrinking of outer jacket 32 may help secure therespective positions of structural support member 30 and/or expandablemember 18 along elongated body 12. This may help minimize the wallthickness of elongated body 12 and, therefore, increase the innerdiameter of elongated body 12 for a given outer diameter by limiting theinclusion of addition layer within the wall construction of elongatedbody 12. In addition, the absence of additional layers (e.g., anadhesive/tie/support layer) that joins inner liner 28 to outer jacket 32may contribute to an increased flexibility of catheter 10. In someexamples, during the heat-shrink process, the various sections of outerjacket 32 may also be bonded (e.g., fused) together.

FIG. 15 is a flow diagram of an example method of aspiration usingcatheter 10. In accordance with the technique shown in FIG. 15, aclinician introduces catheter 10 into vasculature of a patient (150) andnavigates catheter 10 to a target treatment site within a patient. Insome examples, the clinician navigates catheter 10 to the target sitewith the aid of a guidewire, guide catheter or another guide member. Forexample, catheter 10 may be advanced over a guidewire to the targettreatment site. Additionally, or alternatively, the clinician mayintroduce catheter 10 into vasculature of a patient through a guidecatheter that has been initially introduced into vasculature of thepatient.

Once adjacent a target treatment site, expandable member 18 may bedeployed from a collapsed configuration to an expanded configurationwithin the vasculature (152) either manually by a user or automaticallyor otherwise under the control of control circuitry 8 (FIGS. 1 and 2A),e.g., as described with reference to FIG. 16. For example, when distalend 12B of elongated body 12 is positioned as desired relative to atarget treatment site, the user may actuate one or more pull members 36or control circuitry 8 may cause pull members 36 to be actuated in orderto radially bend a set of flexible prongs 34 (FIGS. 1-6B) of expandablemember 18. Additionally or alternatively, the user may actuate one ormore pull members 36, or control circuitry 8 may cause pull members 36to be actuated in order to reorient two or more circumferential struts56 of example expandable member 50 of FIGS. 7-8B. In other examples,expandable member 18 can be configured to expand in response toactuation members other than or in addition to pull members 36.

Additionally or alternatively, control circuitry 8, automatically orbased on input from a user received via user input device 20 (FIG. 2A),may deactivate magnetic device 74 in order to remove a magneticattractive force acting upon a set of permanent magnetic strips 79 ormagnetic material 78 of example expandable member 68 (FIGS. 9A-9D) andexpandable member 70 (FIGS. 10A and 10B). Additionally or alternatively,control circuitry 8, automatically or based on input from a userreceived via user input device 20, may actuate magnetic device 74 inorder to magnetically repel one or more permanent magnetic strips 81B ofexample expandable member 90 (FIGS. 11A and 11B). Additionally oralternatively, the user or control circuitry 8 may proximally withdrawmagnet 107 in order to remove a magnetic attractive force acting uponbody structure 77 of example expandable member 105 (FIGS. 12A and 12B)to cause expandable member 105 to expand radially outward. Additionallyor alternatively, the user or control circuitry 8 may proximally insertmagnet 107 in order to apply a magnetic repulsive force acting upon bodystructure 85 of example expandable member 110 (FIGS. 13A and 13B) tocause expandable member 110 to expand radially outward.

After mouth 13 of catheter 10 is positioned as desired proximate athrombus in the vasculature, control circuitry 8, alone or based oninput from a user received via user input device 20, controls suctionsource 4 to apply a suction force to lumens 22, 25 of catheter 10 toaspirate the thrombus from the vasculature via the lumens 22, 25 (154).

In some, but not all, examples, control circuitry 8 is configured tocontrol a cyclical expanding and contracting of expandable member 18between the contracted and expanded configurations according to anexpansion frequency and while expandable member 18 is in the vasculatureof the patient proximate a thrombus, which may improve the outcome of anaspiration procedure. The expansion frequency can be a fixed frequencyover a period of time (e.g., a treatment session) or can vary over theperiod of time.

FIG. 16 is a flow diagram of an example method of controlling expandablemember 18 according to an expansion frequency. The method of FIG. 16 isprimarily described with reference to aspiration system 2A of FIG. 1Aand expandable member 18 of FIGS. 2A and 2B, but can be used with anysuitable aspiration system and/or any of the expandable membersdescribed herein. In addition, any or all of the technique shown in FIG.16 may be performed by control circuitry of another device in additionto or instead of control circuitry 8 of aspiration system 2A.

In accordance with the technique shown in FIG. 16, control circuitry 8determines an expansion frequency for expanding and contractingexpandable member 18 (160), and then controls the expansion andcontraction of expandable member 18 based on the determined expansionfrequency (162). The expansion frequency can be, for example, thefrequency with which control circuitry 8 controls expandable member 18to move between a fully or partially expanded configuration and a lessexpanded configuration or a fully collapsed configuration. In someexamples, the expansion frequency indicates the number of timesexpandable member 18 is in the expanded configuration or the contractedconfiguration per unit of time. For ease of description, the expansionfrequency is primarily referred to describe the timing with whichcontrol circuitry 8 causes expandable member 18 to move between anexpanded configuration and a contracted configuration. The “expanded”configuration can be a fully expanded or a partially expandedconfiguration, and the “contracted” configuration can be a less expandedstate (e.g., a fully contracted configuration or a partially contractedconfiguration). In some examples, the expansion frequency of expandablemember 18 may be between about 0.5 Hz and about 30 Hz, such as about 1Hz to about 15 Hz, or about 5 Hz to about 10 Hz. As some non-limitingexamples, the expansion frequency may be about 1 Hz, about 5 Hz, about10 Hz, or about 15 Hz, according to one or more of the examples detailedfurther below. In some examples, 1 Hz may correspond to a cardiac cycleof some patients.

It is believed that cyclically controlling the expansion and contractionof expandable member 18 according to a particular expansion frequencymay more quickly and/or more effectively remove a thrombus from a bloodvessel of a patient by varying an amount of suction force applied to thethrombus. For example, a more-expanded configuration of expandablemember 18 increases cross-sectional area of mouth 13 of catheter 10 (thecross-section being taken in a direction orthogonal to longitudinal axis26 of elongated body 12), which may result in a greater amount ofsuction force (from suction source 4) being applied to an outer surfaceof the thrombus proximate mouth 13 compared to the suction force appliedwhen expandable member 18 is a more-contracted configuration. Controlcircuitry 8 can cause expandable member 18 to move between the expandedand contracted configurations according to the expansion frequency whilesuction source 4 (FIG. 1A) is applying a steady-state, constant orsubstantially constant suction force (referred to herein as non-cyclicaspiration) to lumen 22 of catheter 10 or while suction source 4 ismodifying the suction force (referred to herein as cyclic aspiration) tolumen 22 of catheter 10. In any of these examples, the expansionfrequency can be fixed or control circuitry 8 can change the expansionfrequency over time (e.g., during an aspiration procedure).

Control circuitry 8 can determine the expansion frequency (160) usingany suitable technique. As some non-limiting examples, control circuitry8 may determine the expansion frequency based on user input, based on avalue stored in memory 9 (FIGS. 1A and 1B) or a memory of anotherdevice, based on a natural frequency (e.g., a resonant frequency) of athrombus, based on a cardiac cycle of a patient, and/or based on asuction frequency of a suction source 4. In cyclic aspiration examples,the suction frequency of suction source 4 is the frequency with whichsuction source 4 cycles the suction force between a relatively highsuction force and a relatively low suction force. In some examples, thesuction frequency is modified by control of only a pump (if present) ofsuction source 4, of only the evacuation volume, or of only pulsator 7(if present), or of any combination of those components. The suctionfrequency can be determined using any suitable technique, such as basedon user input, based on the natural frequency (e.g., resonant frequency)of a thrombus, or based on a cardiac cycle of a patient.

In some examples, control circuitry 8 determines the expansion frequency(160) by at least receiving user input indicating the expansionfrequency via user-input device 20 or another user input mechanism. Forexample, user-input device 20 or another user input mechanism caninclude a button, a keypad, a touchscreen, a microphone configured toreceive voice commands, or the like, through which the user can input aselected expansion frequency. In some examples, control circuitry 8 isconfigured to receive user input selecting an expansion frequency from aplurality of predetermined expansion frequencies (e.g., stored by memory9 of aspiration system 2A or a memory of another device). In theseexamples, user-input device 20 may include a display, a rotating dial,or the like that presents the predetermined expansion frequencies to theuser, from which the user can select one or more expansion frequenciesfor controlling the expansion of expandable member 18. In addition to orinstead of determining the expansion frequency based on user input, insome examples, control circuitry 8 is configured to receive user inputindicating a desired expansion frequency value.

In some examples, sensing circuitry 11 is configured to detect a naturalfrequency (e.g., a resonant frequency) of a clot within the patient'svasculature. As one example, the natural frequency of the clot may bebetween about 5 Hz and 10 Hz. In such examples, control circuitry 8 maydetermine the expansion frequency of expandable member 18 (160) basedthe signal generated by sensing circuitry 11 and indicative of thenatural frequency of the clot. The contact between a thrombus and thevasculature in which the thrombus is positioned may include certainproperties such that, when the suction force with which aspirationsystem 2A aspirates the thrombus is periodically modified according to aparticular frequency, the thrombus may more effectively become dislodgedand aspirated into lumens 22, 25 of catheter 10.

In other examples, the expansion frequency is predetermined. In theseexamples, control circuitry 8 may determine the expansion frequency(160) by retrieving the predetermined expansion frequency from memory 9or a memory of another device and without any user input indicating theexpansion frequency.

In addition to or instead of any of the other previous examples fordetermining an expansion frequency, in some examples, control circuitry8 is configured to determine the expansion frequency (160) based on acardiac cycle of a patient. It is believed that coordinating the extentto which expandable member 18 is expanded with the cardiac cycle mayimpact the amount of suction force applied to thrombus proximate mouth13. For example, synchronizing the expansion, or the attainment of theexpanded state of, expandable member 18 with certain parts of thecardiac cycle (e.g., diastole or systole) may more quickly and moreeffectively remove a thrombus from a blood vessel of a patient thanapplying a continuous or steady suction force, or other forms of cyclicaspiration.

A cardiac cycle includes different phases, such as diastole, duringwhich the heart muscles are relaxed and a heart chamber fills withblood, and systole, during which the heart muscles contract and pumpblood out of the heart chamber. For example, in a patient with a healthyheart, atrial systole occurs during ventricular diastole to activelyfill the ventricles during their diastole. In some examples, the phasesof a cardiac cycle can include cardiac diastole, atrial systole, andventricular systole. Atrial systole can be associated with a P-wave of aPQRST complex of an electrical cardiac signal, such as a cardiacelectrogram (EGM) or electrocardiogram (ECG), and ventricular systolecan be associated with a Q-deflection of the PQRST complex of theelectrical cardiac signal. Systole referenced herein may refer to atrialsystole or ventricular systole. In addition, diastole referenced hereinmay refer to atrial diastole or ventricular diastole. In addition to orinstead of these phases, the phases of a cardiac cycle can be describedby the fluid flow in the heart. As an example, the phases of a cardiaccycle can be referred to as isovolumetric relaxation, ventricularfilling, ventricular filling with atrial systole, isovolumetriccontraction, and ejection.

In some examples, control circuitry 8 may first determine (e.g.,measure, detect, or receive from another device) a cardiac cycle of thepatient, and then determine the expansion frequency of expandable member18 based on the cardiac cycle. For example, control circuitry 8 canselect the expansion frequency such that expandable member 18 is in itsexpanded configuration at certain parts of the cardiac cycle (e.g.,systole or diastole) and in its contracted configuration at other partsof the cardiac cycle (e.g., the other of systole or diastole). In theseexamples, as well as other examples described herein, the expansionfrequency changes over time (e.g., heartbeat to heartbeat, or every fewheartbeats) as the cardiac cycle of the patient changes (e.g., becomesshorter or faster, or speeds up or slows down over time. As one example,the cardiac cycle of the patient at one point in time may be on theorder of 60 beats per minute (bpm). In some such examples, controlcircuitry 8 may select the expansion frequency to be on the order ofabout 1 Hz.

Control circuitry 8 of aspiration system 2A can determine a cardiaccycle (e.g., the current phase of a cardiac cycle) using any suitabletechnique. For example, control circuitry 8 can determine a currentphase of a cardiac cycle of a patient based on an electrical cardiacsignal, a blood pressure, blood oxygen saturation, or anotherphysiological parameter that changes as a function of a cardiac cycle ofthe patient. In some examples, aspiration system 2A includes or isotherwise communicatively coupled to sensing circuitry 11 configured togenerate a signal indicative of a physiological parameter of the patientindicative of the cardiac cycle, and control circuitry 8 is configuredto receive the signal and determine the cardiac cycle (e.g., a specificphase of the cardiac cycle) based on the signal. The signal can include,for example, one or more of an ECG, an EGM, a photoplethysmogram (PPG),a heart sound phonocardiogram, or a blood pressure signal. Sensingcircuitry 11 can include, for example, one or more of anelectrocardiogram sensor, an electrogram sensor, a blood oxygensaturation sensor, or an arterial blood pressure sensor.

In addition to or instead of receiving physiological signals fromsensing circuitry 11, in some examples, control circuitry 8 may receivesignals from another device that determines the current part of thecardiac cycle and transmits the determined part of the cardiac cycle tocontrol circuitry 8. Thus, although not shown in FIG. 1A, in someexamples, aspiration system 2A includes communication circuitryconfigured to receive information from another device. The communicationcircuitry may be operable to communicate with external devices via oneor more networks by transmitting and/or receiving network signals on theone or more networks. For example, control circuitry 8 may use thecommunication circuitry to transmit and/or receive radio signals on aradio network such as a cellular radio network, or on a satellitenetwork. Examples of such communication circuitry include a networkinterface card (e.g. such as an Ethernet card), an optical transceiver,a radio frequency transceiver, or any other type of device that can sendand/or receive information. Other examples of communication circuitrymay include Near-Field Communications (NFC) units, Bluetooth® radios,short wave radios, cellular data radios, wireless network (e.g., Wi-Fi®)radios, as well as universal serial bus (USB) controllers.

In some examples, control circuitry 8 may determine the expansionfrequency (160) based on an operating frequency of a suction source,such as a suction frequency of suction source 4 of aspiration system 2A.It is believed that in some cases, controlling and/or varying the amountof suction force applied to lumen 22 of aspiration catheter 10 may morequickly and more effectively remove a thrombus from a blood vessel of apatient than applying a continuous or steady suction force. The amountof suction force generated by suction source 4 may be varied accordingto a particular suction frequency or other timing. In some examples,control circuitry 8 is configured to control the suction force appliedby suction source 4 (FIG. 1A) or pump 5 (FIG. 1B) to catheter 10 bymodifying the operation of suction source 4 to vary the suction forceapplied by suction source 4 to inner lumen 22 (e.g., by controlling themotor speed, or stroke length, volume or frequency, or other operatingparameters, of suction source 4) and/or by operating, or controlling thestate of, pulsator 7 (FIG. 1B), if present, positioned between pump 5(or discharge reservoir 6, where present) and catheter 10. As discussedabove, pulsator 7 can fluidically couple or uncouple the catheter 10 toor from the suction source 4 as needed. Pulsator 7 can comprise a valve,tubing clamp, tubing pincher, fluid switch, or the like, preferablyconfigured for selective actuation as needed to fluidically couple oruncouple catheter 10 to or from pump 5 in accordance with control ofaspiration system 2B.

Accordingly, in some examples, control circuitry 8 may first determine asuction frequency of suction source 4, and then determine the expansionfrequency based on the suction frequency. For example, control circuitry8 may determine the expansion frequency to be equivalent to orcorrelated with the suction frequency. In some examples, controlcircuitry 8 can determine the expansion frequency based on the suctionfrequency by at least selecting the expansion frequency to coordinatethe time at which expandable member 18 is in its expanded configurationwith the time at which suction source 4 is applying a relativelygreatest suction force to lumen 22 and the time at which expandablemember is in its contracted configuration (or a less expanded state)with the time at which suction source 4 is applying less suction force,such as no suction force or other suction force less than the relativelygreatest suction force.

In some other examples in which control circuitry 8 varies an amount ofsuction force, but not according to any periodic suction frequency,control circuitry 8 may still correlate an expansion and contraction ofexpandable member 18 with a relative amount of suction force of suctionsource 4. For example, control circuitry 8 may vary the strength of thesuction force or vacuum pressure of suction source 4 such that, as thevacuum pressure increases (e.g., via a user-input device and/or controlcircuitry 8), expandable member 18 expands by a proportional amount. Forexample, if during an aspiration procedure, suction source 4 cyclessuction force between a minimum vacuum pressure and a maximum vacuumpressure, control circuitry 8 may control expandable member 18 toachieve an expanded configuration when the maximum vacuum pressure isapplied. In other examples, expandable member 18 may be configured toremain in a contracted configuration until suction source 4 appliesmaximum vacuum pressure, at which time control circuitry 8 causesexpandable member 18 to transition to a partially expanded or fullyexpanded configuration. In other examples, suction source 4 isconfigured to apply constant suction from to lumen 22 of catheter 10, inwhich case control circuitry 8 does not consider the frequency withwhich suction source 4 applies suction force to lumens 22, 25 whendetermining the expansion frequency.

Control circuitry 8 can determine the suction frequency using anysuitable technique. Similar to a direct determination of the expansionfrequency, control circuitry 8 may determine the suction frequency basedon one or more of user input, a resonant frequency of a clot, apredetermined value stored in memory 9, or a cardiac cycle of a patient,as non-limiting examples.

For example, control circuitry 8 may determine the suction frequency byreceiving user input via user-input device 20 or by retrieving thesuction frequency from memory 9. The user input can, for example,indicate a quantitative or qualitative value for desired suctionfrequency. In some examples, control circuitry 8 is configured toreceive user input selecting a suction frequency from a plurality ofpredetermined pump frequencies (e.g., stored by memory 9 of aspirationsystem 2A or a memory of another device).

In some examples, control circuitry 8 is configured to determine thesuction frequency based on a cardiac cycle of a patient, using similartechniques to those described above with respect to determining anexpansion frequency based on a cardiac cycle. Control circuitry 8 maythen determine the expansion frequency of expandable member 18 based onbased on the cardiac cycle of the patient, e.g., to coordinate theexpanded and contracted configurations of expandable member 18 and theapplication of relatively high suction force and relatively low or nosuction force with selected or predetermined parts of a cardiac cycle.

For example, after determining the cardiac cycle of the patient, controlcircuitry 8 may determine a suction frequency so as to control (e.g.,strategically vary) a suction force of suction source 4 (e.g., viadirect control of a pump, via controlling an associated pulsator 7implemented as a valve, or fluid switch, or via other techniques ofcontrolling suction source 4, as discussed herein) in accordance withthe cardiac cycle. For example, control circuitry 8 can control suctionsource 4 to apply a first suction force to inner lumen 22 of catheter 10during a first part of a cardiac cycle (e.g., diastole or systole) togenerate a first suction force at mouth 13 of catheter 10, and controlsuction source 4 to apply a second suction force to inner lumen 22during another part of the cardiac cycle (e.g., the other of diastole orsystole) to generate a second suction force at mouth 13 of catheter 10,the first suction force being different from the second suction force.In some examples, the first suction force is greater than the secondsuction force. In other examples, the first suction force is less thanthe suction force.

For example, the first suction force or the second suction force can bezero such that suction source 4 does not actively apply any suctionforce to catheter 10 during the respective first or second part of thecardiac cycle. However, in some cases, even if suction source 4 is notactively applying a suction force to catheter 10, there may be someresidual vacuum in inner lumen 22 of catheter 10 due to its length andthe time required for the pressure in inner lumen 22 to equalize withthe environment external to catheter 10 at mouth 13. Thus, even whensuction source 4 is in an off-phase, in which suction source 4 is notactively operating to apply a suction force to catheter 10, a negativepressure in inner lumen 22 may still be observed. Thus, controlcircuitry 8 can be configured to cycle suction source 4 between anon-phase and an off-phase based on the cardiac cycle without causing thepressure differential between inner lumen 22 and the environmentexternal to catheter 10 at mouth 13 to be zero.

In some examples, control circuitry 8 is configured to control suctionsource 4 to apply a suction force to lumen 22 of catheter 10, theapplied suction force having a magnitude between a first suction forceand a second suction force greater than the first suction force. Forexample, control circuitry 8 can be configured to control the suctionforce applied by suction source 4 to lumen 22 by at least controllingsuction source 4 to cycle the suction force between the first and secondsuction forces according to a predetermined frequency or according to acardiac cycle of a patient. The suction force range bounded by the firstand second suction forces may be referred to as a suction force window.In some examples, the first suction force is 0 millimeters of mercury(mmHg). In some examples, control circuitry 8 controls suction source 4to apply a greatest suction force of the suction force window to innerlumen 22 of catheter 10 during diastole. In these examples, controlcircuitry 8 may control suction source 4 to apply a lowest suction forceof the suction force window to inner lumen 22 during systole or duringanother part of the cardiac cycle. Aligning a relatively highest (withinthe suction force window) suction force with diastole (e.g., betweenheart beats) may enable aspiration system 2A to apply a relativelygreatest suction force to a thrombus when the blood vessel is relaxedand, therefore, may be less engaged with the thrombus.

In other examples, control circuitry 8 controls suction source 4 toapply a greatest suction force of the suction force window to innerlumen 22 (and/or controls expandable member 18 to reach its expandedstate) of catheter 10 during systole. In these examples, controlcircuitry 8 may control suction source 4 to apply a lowest suction forceof the suction force window to inner lumen 22 (and/or controlsexpandable member 18 to reach its expanded state) during diastole orduring another part of the cardiac cycle. Aligning a relatively highest(within the suction force window) suction force (and/or a relativelymost expanded state of expandable member 18) with diastole may enableaspiration system 2A to establish a greater pressure differentialbetween inner lumen 22 of catheter 10 and the blood vessel, as the bloodpressure within the blood vessel may be greater during systole thanduring diastole.

During a cardiac cycle, control circuitry 8 may cycle suction source 4between the highest and lowest vacuum pressures of the suction forcewindow at a frequency of about 0.5 Hertz (Hz) to about 5 Hz (e.g.,within 5%, 10%, or 20% of these values), or from about 0.5 Hz to about10 Hz, or to about 20 Hz. In examples in which the lower bound of thesuction force window is 0 mmHg, suction source 4 can be considered to bein an off-phase at the lower bound of the suction force window and in anon-phase at the higher bound of the suction force window.

After determining the expansion frequency (160), control circuitry 8controls the expansion and contraction of expandable member 18 based onthe determined expansion frequency (162). For example, control circuitry8 can cause expandable member 18 to transition between a fullycontracted configuration and a fully expanded configuration, or betweena fully contracted configuration and a partially expanded configuration,or between a partially contracted configuration and a partially expandedconfiguration, or between a partially contracted configuration and afully expanded configuration, according to the determined expansionfrequency. For example, once adjacent a target treatment site,expandable member 18 may be cyclically deployed from at least apartially contracted configuration (e.g., shown in FIGS. 2A, 3A, 3B, 5,7, 9C, 9D, 11A, 12B) to at least a partially expanded configuration(e.g., shown in FIGS. 2B, 3C, 8B, 9A, 9B, 10A, 10B, 11B, and 12A) withinthe vasculature, under the control of control circuitry 8 (FIGS. 1 and2A).

As an example, with reference to the examples of expandable member 18discussed with reference to FIGS. 2A-6B, control circuitry 8 may controlan actuation mechanism to proximally withdraw pull members 36 in orderto radially bend a set of flexible prongs 34 and expand expandablemember 18 to the expanded state of expandable member 18 and release thepull members 36 to return expandable member 18 to a contractedconfiguration, where the proximal withdrawal and release of the pullmembers 36 occurs according to the expansion frequency. In someexamples, the actuation mechanism may include a relatively small batteryand an electric motor contained within handle 14 (FIG. 2A). In some suchexamples, the electric motor is configured to drive a linear movement ofpull members 36 back and forth along longitudinal axis 26.

Additionally or alternatively, control circuitry 8 may control theactuation mechanism to cycle, according to the expansion frequency,between proximally withdrawing pull members 36 in order to reorient twoor more circumferential struts 56 of example expandable member 50 ofFIGS. 7-8B and expand expandable member 50, and releasing the pullmembers 36 return expandable member 18 to a compressed state.

In addition to or instead of the examples including pull members 36 toexpand and contract an expandable member, in some examples, controlcircuitry 8 may cyclically expand and contract an expandable member byat least deactivating magnetic device 74 in order to remove a magneticattractive force acting upon a set of permanent magnetic strips 79 ormagnetic material 78 of example expandable member 68 (FIGS. 9A-9D) andexpandable member 70 (FIGS. 10A and 10B), according to the determinedexpansion frequency. Additionally or alternatively, control circuitry 8may cyclically actuate magnetic device 74 in order to magnetically repelone or more permanent magnetic strips 81B of example expandable member90 (FIGS. 11A and 11B), according to the determined expansion frequency.Additionally or alternatively, control circuitry 8 may cyclicallyproximally withdraw and distally insert magnet 107 in order to remove amagnetic attractive force acting upon body structure 77 of exampleexpandable member 105 (FIGS. 12A and 12B) to cause expandable member 105to expand radially outward, according to the determined expansionfrequency. Additionally or alternatively, control circuitry 8 maycyclically distally insert and proximally withdraw magnet 107 in orderto apply a magnetic repulsive force acting upon body structure 85 ofexample expandable member 110 (FIGS. 13A and 13B) to cause expandablemember 110 to expand radially outward, according to the determinedexpansion frequency.

In examples in which the expansion frequency and/or the suctionfrequency are determined based on a cardiac cycle of a patient, controlcircuitry 8 can be configured to modify (e.g., vary) the amount ofsuction force present at mouth 13 of catheter 10 at various parts of thecardiac cycle by controlling the extent to which expandable member 18 isexpanded at various parts of the cardiac cycle. For example, controlcircuitry 8 is configured to control expandable member 18 to expand toan expanded configuration during a first part of the cardiac cycle(e.g., to assume the expanded configuration during the first part of thecardiac cycle) and to control expandable member 18 to contract during asecond part of the cardiac cycle different from the first part (e.g., toassume the contracted configuration during the second part of thecardiac cycle). As an example, the second part can correspond todiastole, such as, but not limited to, the start of diastole, amid-point of diastole, or an end of diastole. As another example, thesecond part of the cardiac cycle can correspond to systole, such as, butnot limited to, the start of systole, a mid-point of systole, or an endof systole. As yet another example, the second part of the cardiac cyclecan correspond to a maximum ejection phase of the cardiac cycle (e.g.,as indicated by an M-wave of a PQRST complex of an electrical cardiacsignal). Other manners of controlling the cyclical expansion ofexpandable member 18 based on the cardiac cycle of a patient can be usedin other examples.

As one example, control circuitry 8 may control expandable member 18 tocontract or be in a fully or partially contracted configuration duringsystole or during another part of the cardiac cycle. Expandingexpandable member 18 or causing expandable member to be in a partiallyor fully expanded configuration during diastole (e.g., between heartbeats) may enable aspiration system 2A to apply a relatively greatestsuction force to a thrombus when the blood vessel is relaxed and,therefore, may be less engaged with the thrombus.

In other examples, control circuitry 8 controls expandable member 18 toexpand or be in a fully or partially expanded configuration duringsystole. In these examples, control circuitry 8 may control expandablemember 18 to contract or be in a fully or partially contractedconfiguration during diastole or during another part of the cardiaccycle. Expanding expandable member 18 or causing expandable member to bein a partially or fully expanded configuration during diastole mayenable aspiration system 2A to establish a greater pressure differentialbetween inner lumen 22 of catheter 10 and the blood vessel, as the bloodpressure within the blood vessel may be greater during systole thanduring diastole.

In some examples in which the expansion frequency is determined based ona suction frequency and/or an amount of suction force of suction source4, control circuitry 8 may be configured to control the amount ofsuction force applied by suction source 4 and the cyclical expansion ofexpandable member 18 according to a common frequency, e.g., expandablemember 18 is cyclically expanded in accordance with periodichigher-pressure “pulls” of suction source 4. In other examples, controlcircuitry 8 may cyclically expand and contract expandable member 18while suction source 4 applies a substantially constant suction force(e.g., constant but for functionally negligible variations) to lumen 22of catheter 10. In other examples, control circuitry 8 may be configuredto independently control a suction frequency of suction source 4 and theexpansion frequency of expandable member 18, wherein the suctionfrequency and the expansion frequency are either correlated oruncorrelated with one another. For example, the expansion frequency maybe a multiple or a fraction of the suction frequency, or vice versa. Inexamples in which both the suction frequency and the expansion frequencyare determined based on the cardiac cycle, control circuitry 8 maysynchronize both the suction frequency and the expansion frequency withthe cardiac cycle to cause suction source 4 to apply increased suctionforces when expandable member 18 is in an expanded state, thereby moreeffectively removing a thrombus during an aspiration procedure.

In some examples, electrical energy may be applied to expandable member18 to better engage the clot. For example, control circuitry 8 cancontrol an energy source, e.g., of aspiration system 2A, to delivery anelectrical energy to the exposed portions of expandable member 18 viaone or more electrical conductors (not shown) electrically coupled toexpandable member 18. The electrical conductors may be within lumen 22,external to elongated body 12, or embedded in elongated body 12. Theelectrical energy may be positively charged to electrostatically engagea clot. Characteristics of the electrical energy may be adjusted tobetter engage the clot, such as polarity, or an amount or type ofcurrent delivered. For example, pulsed direct current may be employed,optionally with a non-square and/or non-negative waveform.

In some examples, the technique of FIG. 16 further includes removingcatheter 10 from the vasculature of the patient once the procedure iscomplete. For example, expandable member 18 may be collapsed into acontracted configuration as described above, and catheter 10 may beproximally withdrawn from the vasculature of the patient.

The techniques described in this disclosure, including those attributedto control circuitry 8, and sensing circuitry 11, or various constituentcomponents, may be implemented, at least in part, in hardware, software,firmware or any combination thereof. For example, various aspects of thetechniques may be implemented within one or more processors, includingone or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalentintegrated or discrete logic circuitry, as well as any combinations ofsuch components, embodied in programmers, such as clinician or patientprogrammers, medical devices, or other devices. Processing circuitry,control circuitry, and sensing circuitry, as well as other processorsand controllers described herein, may be implemented at least in partas, or include, one or more executable applications, applicationmodules, libraries, classes, methods, objects, routines, subroutines,firmware, and/or embedded code, for example. In addition, analogcircuits, components and circuit elements may be employed to constructone, some or all of the control circuitry 8, and sensing circuitry 11,instead of or in addition to the partially or wholly digital hardwareand/or software described herein. Accordingly, analog or digitalhardware may be employed, or a combination of the two. Whetherimplemented in digital or analog form, or in a combination of the two,control circuitry 8 can comprise a timing circuit configured to commandthe expansion and contraction of expandable member 18, 50, 68, 70, 90 ofa catheter according to a predetermined frequency, the application of asuction force (via, e.g., command of a pulsator in fluid communicationwith suction source 4) in synchrony with the patient's cardiac cycle oranother predetermined frequency, or any combination thereof.

In one or more examples, the functions described in this disclosure maybe implemented in hardware, software, firmware, or any combinationthereof. If implemented in software, the functions may be stored on, asone or more instructions or code, a computer-readable medium andexecuted by a hardware-based processing unit. The computer-readablemedium may be an article of manufacture including a non-transitorycomputer-readable storage medium encoded with instructions. Instructionsembedded or encoded in an article of manufacture including anon-transitory computer-readable storage medium encoded, may cause oneor more programmable processors, or other processors, to implement oneor more of the techniques described herein, such as when instructionsincluded or encoded in the non-transitory computer-readable storagemedium are executed by the one or more processors. Examplenon-transitory computer-readable storage media may include RAM, ROM,programmable ROM (PROM), erasable programmable ROM (EPROM),electronically erasable programmable ROM (EEPROM), flash memory, a harddisk, a compact disc ROM (CD-ROM), a floppy disk, a cassette, magneticmedia, optical media, or any other computer readable storage devices ortangible computer readable media.

In some examples, a computer-readable storage medium comprisesnon-transitory medium. The term “non-transitory” may indicate that thestorage medium is not embodied in a carrier wave or a propagated signal.In certain examples, a non-transitory storage medium may store data thatcan, over time, change (e.g., in RAM or cache).

The functionality described herein may be provided within dedicatedhardware and/or software modules. Depiction of different features asmodules or units is intended to highlight different functional aspectsand does not necessarily imply that such modules or units must berealized by separate hardware or software components. Rather,functionality associated with one or more modules or units may beperformed by separate hardware or software components, or integratedwithin common or separate hardware or software components. Also, thetechniques could be fully implemented in one or more circuits or logicelements.

The following clauses provide some examples of the disclosure.

Clause 1: In some examples, a catheter includes an elongated bodydefining an inner lumen and a central longitudinal axis, the elongatedbody including an expandable member at a distal portion of the elongatedbody, the expandable member including a plurality of prongs disposedaround the central longitudinal axis; and a pull member coupled to atleast one prong of the plurality of prongs, wherein the at least oneprong is configured to expand radially outward relative to the centrallongitudinal axis in response to a tensile force applied to the pullmember.

Clause 2: In some examples of the catheter of clause 1, the catheterfurther includes a plurality of pull members including the pull member,wherein each pull member of the plurality of pull members is coupled toa respective prong of the plurality of prongs, and wherein when thetensile force is applied to the plurality of pull members, the pluralityof prongs expand radially outward to expand the expandable memberradially outward.

Clause 3: In some examples of the catheter of clause 1 or clause 2, theexpandable member includes a laser-cut nickel-titanium structure.

Clause 4: In some examples of the catheter of any of clauses 1-3, eachprong includes a generally oval or flower-petal shape.

Clause 5: In some examples of the catheter of any of clauses 1-3, eachprong includes a generally rectangular-prism shape.

Clause 6: In some examples of the catheter of any of clauses 1-5, the atleast one prong includes one or more hinges configured to define a pivotpoint of the prong along which the prong bends in response to thetensile force from the pull member.

Clause 7: In some examples of the catheter of clause 6, each hingeincludes one or more openings cut into a material of the respectiveprong.

Clause 8: In some examples of the catheter of clause 6 or clause 7, eachprong includes two hinges.

Clause 9: In some examples of the catheter of any of clauses 6-8, eachprong includes one hinge positioned at a proximal-most end of theexpandable member.

Clause 10: In some examples of the catheter of any of clauses 1-9, theexpandable member further includes a flexible membrane disposed over orunder the prongs.

Clause 11: In some examples of the catheter of clause 9, the polymerincludes a fluid-impermeable polymer.

Clause 12: In some examples of the catheter of any of clauses 1-11, theexpandable member is mechanically coupled to the structural supportmember at a plurality of circumferential positions of the structuralsupport member.

Clause 13: In some examples of the catheter of any of clauses 1-12, theelongated body defines an inner lumen, and wherein the expandable memberdefines a distal opening to the inner lumen.

Clause 14: In some examples of the catheter of any of clauses 1-13, aninner surface of the expandable member includes a plurality ofengagement members configured to engage a thrombus.

Clause 15: In some examples of the catheter of any of clauses 1-14, theexpandable member defines a tapered distal tip of the elongated body.

Clause 16: In some examples, a catheter includes an elongated bodyincluding a proximal portion and a distal portion; a handle coupled tothe proximal portion of the elongated body; and an expandable membercoupled to the distal portion of the elongated body, the expandablemember including a plurality of flexible prongs disposedcircumferentially around a central longitudinal axis of the catheter;and an elongated pull member defining a proximal pull end and a distalpull end, wherein: the distal pull end is rigidly coupled to at leastone prong of the plurality of prongs; the proximal pull end ismechanically coupled to an actuator device on the handle; and the atleast one prong is configured to expand radially outward from thecentral longitudinal axis in response to a tensile force applied via thepull member in response to actuation of the actuator device.

Clause 17: In some examples of the catheter of clause 16, the catheterfurther includes a plurality of pull members including the pull member,wherein each pull member of the plurality of pull members is coupled toa respective prong of the plurality of prongs, and wherein the tensileforce is applied to the plurality of pull members, the plurality ofprongs expand radially outward to expand the expandable member radiallyoutward.

Clause 18: In some examples of the catheter of clause 16 or clause 17,the expandable member includes a laser-cut nickel titanium structure.

Clause 19: In some examples of the catheter of any of clauses 16-18,each prong includes a generally oval or flower-petal shape.

Clause 20: In some examples of the catheter of any of clauses 16-18,each prong includes a generally rectangular-prism shape.

Clause 21: In some examples, a method includes controlling, by controlcircuitry, an expandable member of a catheter to expand radially outwardfrom a contracted configuration to an expanded configuration, whereinthe expandable member includes a plurality of prongs disposed around thecentral longitudinal axis; and a pull member coupled to at least oneprong of the plurality of prongs, wherein the at least one prong isconfigured to expand radially outward relative to the centrallongitudinal axis in response to a tensile force applied to the pullmember; and controlling, by the control circuitry, the expandable memberto contract radially inward from the expanded configuration to thecontracted configuration.

Clause 22: In some examples of the method of clause 21, controlling theexpandable member to expand radially outward includes controlling anactuation mechanism to apply the tensile force to the pull member.

Clause 23: In some examples of the method of clause 21 or clause 22,controlling the expandable member to contract radially inward includescontrolling the actuation mechanism to release the tensile force appliedto the pull member.

Clause 24: In some examples of the method of any of clauses 21-23, themethod further includes receiving user input, wherein controlling theexpandable member to expand radially outward includes controlling theexpandable member to expand radially outward in response to receivingthe user input.

Clause 25: In some examples of the method of any of clauses 21-24,controlling the expandable member includes controlling, by the controlcircuitry, the expandable member to move between the expandedconfiguration and the collapsed configuration based on a predeterminedexpansion frequency.

Clause 26: In some examples of the method of any of clauses 21-25, thecatheter includes the catheter of any of clauses 1-20.

Clause 27: In some examples, a catheter includes an elongated bodydefining an inner lumen and a central longitudinal axis, the elongatedbody including an expandable member at a distal portion of the elongatedbody, the expandable member including a slidable leg configured to moveproximally and distally along the central longitudinal axis; a firstfixed leg; a second fixed leg, wherein the slidable leg is disposedbetween the first and second fixed legs; a strut having a first endhingedly connected to the slidable leg and a second end hingedlyconnected to the first fixed leg; and a second strut having a third endhingedly connected to the slidable leg and a fourth end hingedlyconnected to the second fixed leg, wherein a proximal motion of theslidable leg relative to the first and second fixed legs causes thefirst and second fixed legs to expand radially outward.

Clause 28: In some examples of the catheter of clause 27, a leglongitudinal axis of the slidable leg is parallel to the centrallongitudinal axis.

Clause 29: In some examples of the catheter of clause 27 or clause 28,the first strut and the second strut are configured to increase a widthbetween the slidable leg and the respective first and second fixed legsin response to the proximal motion of the slidable leg.

Clause 30: In some examples of the catheter of any of clauses 27-29, theproximal motion of the slidable leg increases a strut angle between theslidable leg and the first and second struts.

Clause 31: In some examples of the catheter of any of clauses 27-30, thefirst and second struts are connected to the slidable leg by arespective first strut hinge and to the respective first and secondfixed legs by a respective second strut hinge.

Clause 32: In some examples of the catheter of clause 31, each of thefirst strut hinge and the second strut hinge includes a C-shaped hingeconfigured to widen in response to the proximal motion of the slidableleg.

Clause 33: In some examples of the catheter of any of clauses 27-32, thecatheter further includes a pull member coupled the slidable leg, thepull member configured to apply a proximal tensile force to the slidableleg to cause the proximal motion of the slidable leg.

Clause 34: In some examples of the catheter of any of clauses 27-33, theexpandable member includes a plurality of slidable legs including theslidable leg; a plurality of struts including the first and secondstruts; and a plurality of fixed legs including the first and secondfixed legs, wherein the fixed legs are disposed circumferentially aroundthe central longitudinal axis, wherein the at least one slidable leg ofthe plurality of slidable legs is disposed between two fixed legs of theplurality of fixed legs and connected to the two fixed legs viarespective struts of the plurality of struts.

Clause 35: In some examples of the catheter of clause 34, the pluralityof struts defines a spiral pattern, wherein circumferentially adjacentstruts are not longitudinally aligned.

Clause 36: In some examples of the catheter of clause 34 or clause 35,the plurality of slidable legs includes four to six slidable legs, andthe plurality of fixed legs includes an equal number of fixed legs asslidable legs.

Clause 37: In some examples of the catheter of any of clauses 27-36, theexpandable member includes a laser-cut nickel-titanium structure.

Clause 38: In some examples of the catheter of any of clauses 27-37, theexpandable member further includes a flexible membrane disposed over orunder the slidable leg and the first and second fixed legs.

Clause 39: In some examples of the catheter of clause 38, the membraneincludes a fluid-impermeable polymer.

Clause 40: In some examples of the catheter of any of clauses 27-39, theelongated body defines an inner lumen, and the expandable member definesa distal opening to the inner lumen.

Clause 41: In some examples of the catheter of any of clauses 27-40, aninner surface of the expandable member includes a plurality ofengagement members configured to engage with a thrombus.

Clause 42: In some examples of the catheter of any of clauses 27-41, theexpandable member defines a tapered distal tip of the elongated body.

Clause 43: In some examples of the catheter of any of clauses 27-42,each of the first and second fixed legs includes one or more leg hingespositioned proximally from the first and second struts.

Clause 44: In some examples, a catheter includes an elongated bodyhaving a proximal portion and a distal portion; a handle coupled to theproximal portion of the elongated body; and an expandable member coupledto the distal portion of the elongated body, the expandable memberincluding a slidable leg configured to move proximally and distallyalong the central longitudinal axis; a first fixed leg; a second fixedleg, wherein the slidable leg is disposed between the first and secondfixed legs; and a strut having a first end hingedly connected to theslidable leg and a second end hingedly connected to the first fixed leg;and a second strut having a first end hingedly connected to the slidableleg and a second end hingedly connected to the second fixed leg, whereina proximal motion of the slidable leg relative to the first and secondfixed legs causes the first and second fixed legs to expand radiallyoutward.

Clause 45: In some examples of the catheter of clause 44, the first andsecond struts are configured to increase a width between the slidableleg and the respective first and second fixed legs in response to theproximal motion of the slidable leg.

Clause 46: In some examples of the catheter of clause 44 or 45, theexpandable member includes a laser-cut nickel-titanium structure.

Clause 47: In some examples, a method includes controlling, by controlcircuitry, an expandable member of a catheter to expand radially outwardfrom a contracted configuration to an expanded configuration, whereinthe expandable member includes a slidable leg configured to moveproximally and distally along the central longitudinal axis; a firstfixed leg; a second fixed leg, wherein the slidable leg is disposedbetween the first and second fixed legs; a strut having a first endhingedly connected to the slidable leg and a second end hingedlyconnected to the first fixed leg; and a second strut having a third endhingedly connected to the slidable leg and a fourth end hingedlyconnected to the second fixed leg, wherein a proximal motion of theslidable leg relative to the first and second fixed legs causes thefirst and second fixed legs to expand radially outward; and controlling,by the control circuitry, the expandable member to contract radiallyinward from the expanded configuration to the contracted configuration.

Clause 48: In some examples of the method of clause 47, controlling theexpandable member to expand radially outward includes controlling anactuation mechanism to proximally move the slidable leg relative to thefirst and second fixed legs.

Clause 49: In some examples of the method of clause 47 or clause 48, theexpandable member further includes a pull member coupled the slidableleg, wherein controlling the actuation mechanism to proximally move theslidable leg relative to the first and second fixed legs includescontrolling the actuation mechanism to apply a proximal tensile force tothe pull member.

Clause 50: In some examples of the method of any of clauses 47-49,controlling the expandable member to contract radially inward includescausing distal movement of the slidable leg relative to the first andsecond fixed legs.

Clause 51: In some examples of the method of any of clauses 47-50, themethod further includes receiving user input, wherein controlling theexpandable member to expand radially outward includes controlling theexpandable member to expand radially outward in response to receivingthe user input.

Clause 52: In some examples of the method of any of clauses 47-51,controlling the expandable member to includes controlling, by thecontrol circuitry, the expandable member to move between the expandedconfiguration and the collapsed configuration based on a predeterminedexpansion frequency.

Clause 53: In some examples of the method of any of clauses 47-52, thecatheter includes the catheter of any of clauses 27-46.

Clause 54: In some examples, a catheter includes an elongated bodydefining an inner lumen and including an expandable member at a distalportion of the elongated body, the expandable member including a bodystructure including a magnetic material, wherein the expandable memberis configured to expand radially outward or contract radially inward inresponse to a magnetic force proximate the expandable member.

Clause 55: In some examples of the catheter of clause 54, the catheterfurther includes a magnetic device configured to generate the magneticforce.

Clause 56: In some examples of the catheter of clause 55, the magneticdevice is fixed relative to the expandable member.

Clause 57: In some examples of the catheter of clause 55, the magneticdevice is movable relative to the expandable member.

Clause 58: In some examples of the catheter of any of clauses 55-57, themagnetic device includes a permanent magnetic configured to generate themagnetic force.

Clause 59: In some examples of the catheter of any of clauses 55-57, themagnetic device includes a solenoid configured to generate the magneticforce when energy is applied to the solenoid.

Clause 60: In some examples of the catheter of clause 59, the solenoidincludes a conductive wire wrapped around a nitinol rod.

Clause 61: In some examples of the catheter of any of clauses 54-60, themagnetic material includes one or more permanent magnetic stripsextending along a central longitudinal axis of the elongated body anddistributed circumferentially around the body structure.

Clause 62: In some examples of the catheter of clause 61, the magneticforce is a magnetic attractive force, and wherein the one or morepermanent magnetic strips includes a plurality of magnetic strips havingmagnetic domains oriented to magnetically repel each other through amagnetic repulsive force, the catheter further including a magneticdevice configured to generate the magnetic attractive force, wherein themagnetic device is configured to magnetically attract the plurality ofmagnetic strips through the magnetic attractive force, the magneticattractive force being stronger than the magnetic repulsive force, suchthat the expandable member collapses into a contracted configurationwhen the magnetic device is applying the magnetic attractive forceproximate to the expandable member.

Clause 63: In some examples of the catheter of clause 62, the magneticrepulsive force is configured to cause the expandable member toself-expand into an expanded configuration when the magnetic device isnot applying the magnetic attractive force proximate to the expandablemember.

Clause 64: In some examples of the catheter of clause 61, the magneticforce is a magnetic repulsive force, wherein the one or more permanentmagnetic strips includes a first permanent magnetic strip and a secondpermanent magnetic strip, the first permanent magnetic strip beingoriented to magnetically attract the second permanent through a magneticattractive force, the catheter further including a magnetic deviceconfigured to generate the magnetic repulsive force, wherein themagnetic device is configured to magnetically repel the second permanentmagnetic strip through the magnetic repulsive force, the magneticrepulsive force being greater than the magnetic attractive force, suchthat the expandable member expands into an expanded configuration whenthe magnetic device applies the magnetic force proximate to theexpandable member.

Clause 65: In some examples of the catheter of any of clauses 54-64, thebody structure defines a plurality of folds configured to guide afolding of the expandable member into a contracted configuration.

Clause 66: In some examples of the catheter of any of clauses 54-60, thecatheter further includes a magnet configured to move into an innerlumen of the expandable member, wherein the magnet is configured tomagnetically attract the magnetic material through the magnetic force tocause the expandable member to contract radially inwards.

Clause 67: In some examples of the catheter of clause 66, the catheterfurther includes a self-expanding structure disposed within the bodystructure, wherein the self-expanding structure is configured to applyan outward radial force to an interior surface of the body structure toexpand the expandable member into an expanded configuration in theabsence of the magnet in the inner lumen of the expandable member.

Clause 68: In some examples of the catheter of any of clauses 54-67, themagnetic material includes a ferromagnetic material embedded within thebody structure.

Clause 69: In some examples of the catheter of clause 68, theferromagnetic material includes iron particles.

Clause 70: In some examples of the catheter of any of clauses 54-69, thebody structure includes a flexible polymer, and wherein the magneticmaterial includes discrete sections of magnetic material connected tothe flexible polymer.

Clause 71: In some examples of the catheter of any of clauses 54-70, thebody structure includes a flexible polymer and the magnetic material isembedded in the flexible polymer.

Clause 72: In some examples, an aspiration system includes a catheterdefining a lumen terminating in a mouth, the catheter including anexpandable member defining the mouth, wherein the expandable memberincludes a body structure including a magnetic material; and a magneticdevice configured to apply a magnetic force proximate to the expandablemember to cause the expandable member to expand radially outward orcontract radially inward.

Clause 73: In some examples of the aspiration system of clause 72, themagnetic device is fixed relative to the expandable member.

Clause 74: In some examples of the aspiration system of clause 72, themagnetic device is movable relative to the expandable member.

Clause 75: In some examples of the aspiration system of any of clauses72-74, the magnetic device includes a permanent magnetic configured togenerate the magnetic force.

Clause 76: In some examples of the aspiration system of any of clauses72-74, the magnetic device includes a solenoid configured to generatethe magnetic force when energy is applied to the solenoid.

Clause 77: In some examples of the aspiration system of clause 76, thesolenoid includes a conductive wire wrapped around a nitinol rod.

Clause 78: In some examples of the aspiration system of any of clauses72-77, the magnetic material includes one or more permanent magneticstrips extending along a central longitudinal axis of the elongated bodyand distributed circumferentially around the body structure.

Clause 79: In some examples of the aspiration system of clause 78, themagnetic force is a magnetic attractive force, and wherein the one ormore permanent magnetic strips includes a plurality of magnetic stripshaving magnetic domains oriented to magnetically repel each otherthrough a magnetic repulsive force, wherein the magnetic device isconfigured to generate the magnetic attractive force, and wherein themagnetic device is configured to magnetically attract the plurality ofmagnetic strips through the magnetic attractive force, the magneticattractive force being stronger than the magnetic repulsive force, suchthat the expandable member collapses into a contracted configurationwhen the magnetic device is applying the magnetic attractive forceproximate to the expandable member.

Clause 80: In some examples of the aspiration system of clause 79, themagnetic repulsive force is configured to cause the expandable member toself-expand into an expanded configuration when the magnetic device isnot applying the magnetic attractive force proximate to the expandablemember.

Clause 81: In some examples of the aspiration system of clause 78, themagnetic force is a magnetic repulsive force, wherein the one or morepermanent magnetic strips includes a first permanent magnetic strip anda second permanent magnetic strip, the first permanent magnetic stripbeing oriented to magnetically attract the second permanent through amagnetic attractive force, wherein the magnetic device is configured togenerate the magnetic repulsive force, and wherein the magnetic deviceis configured to magnetically repel the second permanent magnetic stripthrough the magnetic repulsive force, the magnetic repulsive force beinggreater than the magnetic attractive force, such that the expandablemember expands into an expanded configuration when the magnetic deviceapplies the magnetic force proximate to the expandable member.

Clause 82: In some examples of the aspiration system of any of clauses72-81, the body structure defines a plurality of folds configured toguide a folding of the expandable member into a contractedconfiguration.

Clause 83: In some examples of the aspiration system of any of clauses72-82, the magnetic device includes a magnet configured to move into aninner lumen of the expandable member, wherein the magnet is configuredto magnetically attract the magnetic material through the magnetic forceto cause the expandable member to contract radially inwards.

Clause 84: In some examples of the aspiration system of clause 83, thecatheter further includes a self-expanding structure disposed within thebody structure, wherein the self-expanding structure is configured toapply an outward radial force to an interior surface of the bodystructure to expand the expandable member into an expanded configurationin the absence of the magnet in the inner lumen of the expandablemember.

Clause 85: In some examples of the aspiration system of any of clauses72-84, the magnetic material includes a ferromagnetic material embeddedwithin the body structure.

Clause 86: In some examples of the aspiration system of clause 85, theferromagnetic material includes iron particles.

Clause 87: In some examples of the aspiration system of any of clauses72-86, the body structure includes a flexible polymer and the magneticmaterial includes discrete sections of magnetic material connected tothe flexible polymer.

Clause 88: In some examples of the aspiration system of any of clauses72-87, the body structure includes a flexible polymer and the magneticmaterial is embedded in the flexible polymer.

Clause 89: In some examples, a method includes controlling, by controlcircuitry, an expandable member of a catheter to expand radially outwardfrom a contracted configuration to an expanded configuration, whereinthe expandable member includes a body structure including a magneticmaterial, wherein the expandable member is configured to expand radiallyoutward or contract radially inward in response to a magnetic forceproximate the expandable member; and controlling, by the controlcircuitry, the expandable member to contract radially inward from theexpanded configuration to the contracted configuration.

Clause 90: In some examples of the method of clause 89, controlling theexpandable member to expand radially outward includes controlling amagnetic device to apply the magnetic force proximate the expandablemember.

Clause 91: In some examples of the method of clause 89 or clause 90, thecatheter comprises the catheter of any of clauses 1-18 or the aspirationsystem of any of clauses 19-35.

Clause 92: In some examples, an aspiration system includes a catheterincluding an elongated body defining an inner lumen; and an expandablemember at a distal portion of the elongated body, wherein the expandablemember is configured to expand radially outward from a contractedconfiguration to an expanded configuration; and control circuitryconfigured to control the expandable member to move between the expandedconfiguration and the contracted configuration based on the expansionfrequency.

Clause 93: In some examples of the aspiration system of clause 92, theexpanded configuration is a fully expanded configuration of theexpandable member.

Clause 94: In some examples of the aspiration system of clause 92, theexpanded configuration is a partially expanded configuration of theexpandable member.

Clause 95: In some examples of the aspiration system of any of clauses92-94, the contracted configuration is a fully contracted configurationof the expandable member.

Clause 96: In some examples of the aspiration system of any of clauses92-94, the contracted configuration is a partially contractedconfiguration of the expandable member.

Clause 97: In some examples of the aspiration system of any of clauses92-96, the system further includes a user input device, wherein thecontrol circuitry is configured to receive, via the user input device,user input indicating the expansion frequency.

Clause 98: In some examples of the aspiration system of any of clauses92-97, the control circuitry is configured to determine the expansionfrequency.

Clause 99: In some examples of the aspiration system of clause 98, thecontrol circuitry is configured to determine the expansion frequencybased on a cardiac cycle of a patient.

Clause 100: In some examples of the aspiration system of clause 99, thecontrol circuitry is configured to control the expandable member toexpand radially outward from the contracted configuration to theexpanded configuration according to the expansion frequency by at leastcontrolling the expandable member to expand to the expandedconfiguration during a first part of the cardiac cycle and controllingthe expandable member to contract to the contracted configuration duringa second part of the cardiac cycle.

Clause 101: In some examples of the aspiration system of clause 98, thesystem further includes a suction source configured to apply a suctionforce to the catheter to remove fluid from the catheter, wherein thecontrol circuitry is configured to determine the expansion frequencybased on the suction force applied by the suction source to thecatheter.

Clause 102: In some examples of the aspiration system of clause 101, thecontrol circuitry is configured to control the suction source to cyclethe suction force between first and second suction forces according to asuction frequency, and wherein the control circuitry is configured todetermine the expansion frequency based on the suction frequency.

Clause 103: In some examples of the aspiration system of clause 101, thesuction source is configured to apply a first suction force to thecatheter and a second suction force to the catheter, wherein the controlcircuitry is configured to control the expandable member to expandradially outward from the contracted configuration to the expandedconfiguration according to the expansion frequency by at leastcontrolling the expandable member to expand to the expandedconfiguration when the suction source is applying the first suctionforce to the catheter and controlling the expandable member to contractto the contracted configuration when the suction source is applying thesecond suction force to the catheter.

Clause 104: In some examples of the aspiration system of clause 101, thecontrol circuitry is configured to control the suction force applied bythe suction source to the catheter based on a cardiac cycle of apatient.

Clause 105: In some examples of the aspiration system of clause 98, thecontrol circuitry is configured to determine the expansion frequencybased on a resonant frequency of a thrombus.

Clause 106: In some examples of the aspiration system of any of clauses98-104 or clause 104, the system further includes sensing circuitryconfigured to generate a signal indicative of a cardiac cycle of thepatient or a resonant frequency of a thrombus in vasculature of apatient, wherein the control circuitry is configured to receive thesignal from the sensing circuitry and determine the expansion frequencybased on the signal.

Clause 107: In some examples of the aspiration system of clause 106, thesignal includes at least one of an electrocardiogram, an electrogram, aphotoplethysmogram, a transcranial doppler, or a blood pressure signal.

Clause 108: In some examples of the aspiration system of any of clauses92-107, the expandable member includes a plurality of prongs disposedaround the central longitudinal axis; and a pull member coupled to atleast one prong of the plurality of prongs, wherein the at least oneprong is configured to expand radially outward relative to the centrallongitudinal axis in response to a tensile force applied to the pullmember, and wherein the control circuitry is configured to control theexpandable member to move between the expanded configuration and thecollapsed configuration based on the expansion frequency by at leastcontrolling a timing with which an actuation mechanism applies thetensile force to the pull member based on the expansion frequency.

Clause 109: In some examples of the aspiration system of any of clauses92-108, the expandable member includes a slidable leg configured to moveproximally and distally along a longitudinal axis of the elongated body;a first fixed leg; a second fixed leg, wherein the slidable leg isdisposed between the first and second fixed legs; a strut having a firstend hingedly connected to the slidable leg and a second end hingedlyconnected to the first fixed leg; and a second strut having a third endhingedly connected to the slidable leg and a fourth end hingedlyconnected to the second fixed leg, wherein a proximal motion of theslidable leg relative to the first and second fixed legs causes thefirst and second fixed legs to expand radially outward, and wherein thecontrol circuitry is configured to control the expandable member to movebetween the expanded configuration and the collapsed configuration basedon the expansion frequency by at least controlling the slidable leg tomove proximally and distally based on the expansion frequency.

Clause 110: In some examples of the aspiration system of any of clauses92-109, the expandable member includes a magnetic material, theexpandable member is configured to expand radially outward or contractradially inward in response to a magnetic force proximate the expandablemember, and the control circuitry is configured to control theexpandable member to move between the expanded configuration and thecollapsed configuration based on the expansion frequency by at leastcontrolling a timing with the magnetic force is applied to theexpandable member.

Clause 111: In some examples of the aspiration system of clause 110, thecontrol circuitry is configured to control the timing with which themagnetic force is applied to the expandable member by at leastcontrolling movement of a magnet relative to the expandable member.

Clause 112: In some examples of the aspiration system of clause 110, thecontrol circuitry is configured to control the timing with which themagnetic force is applied to the expandable member by at leastcontrolling application of energy to a solenoid, the solenoid beingconfigured to generate the magnetic force.

Clause 113: In some examples of the aspiration system of any of clauses92-113, the control circuitry is configured to control the expandablemember to move between the expanded configuration and the collapsedconfiguration based on the expansion frequency by at least controllingthe number of times the expandable member is in the expandedconfiguration per unit of time based on the expansion frequency.

Clause 114: In some examples, an aspiration system includes a suctionsource configured to apply a suction force to a catheter to remove fluidfrom the catheter during a medical aspiration procedure; and controlcircuitry configured to control an expandable member of the catheter toexpand and contract during the medical aspiration procedure.

Clause 115: In some examples of the aspiration system of clause 114, thecontrol circuitry is configured to control the expandable member toexpand and contract by at least controlling when the expandable memberis in a contracted configuration and when the expandable member is in anexpanded configuration based on an expansion frequency.

Clause 116: In some examples of the aspiration system of clause 115, theexpanded configuration is a fully expanded configuration or a partiallyexpanded configuration of the expandable member.

Clause 117: In some examples of the aspiration system of clause 115 orclause 116, wherein the contracted configuration is a fully contractedconfiguration or a partially contracted configuration of the expandablemember.

Clause 118: In some examples of the aspiration system of any of clauses115-117, further including a user input device, wherein the controlcircuitry is configured to receive, via the user input device, userinput indicating the expansion frequency.

Clause 119: In some examples of the aspiration system of any of clauses115-117, wherein the control circuitry is configured to determine theexpansion frequency.

Clause 120: In some examples of the aspiration system of any of clauses115-119, further including sensing circuitry configured to generate asignal indicative of a cardiac cycle of the patient or a resonantfrequency of a thrombus in vasculature of a patient, wherein the controlcircuitry is configured to determine the expansion frequency based onthe signal.

Clause 121: In some examples of the aspiration system of any of clauses115-120, the control circuitry is configured to determine the expansionfrequency based on a suction force applied by the suction source to thecatheter.

Clause 122: In some examples of the aspiration system of any of clauses115-121, the control circuitry is configured to determine the expansionfrequency based a resonant frequency of a thrombus.

Clause 123: In some examples of the aspiration system of any of clauses115-120, the system further includes sensing circuitry configured togenerate a signal indicative of a cardiac cycle of the patient or aresonant frequency of a thrombus in vasculature of a patient, whereinthe control circuitry is configured to determine the expansion frequencybased on the signal from the sensing circuitry.

Clause 124: In some examples, a method includes determining, by controlcircuitry, an expansion frequency for an expandable member of acatheter, the catheter including an elongated body defining an innerlumen; and the expandable member at the distal portion of the elongatedbody, wherein the expandable member is configured to expand radiallyoutward from a contracted configuration to an expanded configuration;and controlling, by the control circuitry, the expandable member to movebetween the expanded configuration and the collapsed configuration basedon the expansion frequency.

Clause 125: In some examples of the method of clause 124, the expandedconfiguration is a fully expanded configuration or a partially expandedconfiguration of the expandable member.

Clause 126: In some examples of the method of clause 124 or clause 125,the collapsed configuration is a fully collapsed configuration or apartially collapsed configuration of the expandable member.

Clause 127: In some examples of the method of any of clauses 124-126,controlling the expandable member to move between the expandedconfiguration and the collapsed configuration based on the expansionfrequency includes controlling the number of times the expandable memberis in the expanded configuration per unit of time based on the expansionfrequency.

Clause 128: In some examples of the method of any of clauses 124-127,determining the expansion frequency includes receiving, via a user inputdevice, user input indicating the expansion frequency.

Clause 129: In some examples of the method of any of clauses 124-127,determining the expansion frequency includes determining, by the controlcircuitry, the expansion frequency based on a cardiac cycle of apatient.

Clause 130: In some examples of the method of clause 129, controllingthe expandable member to move between the expanded configuration and thecollapsed configuration based on the expansion frequency includescontrolling the expandable member to expand to the expandedconfiguration during a first part of the cardiac cycle and controllingthe expandable member to contract to the contracted configuration duringa second part of the cardiac cycle.

Clause 131: In some examples of the method of any of clauses 124-128,wherein determining the expansion frequency includes determining, by thecontrol circuitry, the expansion frequency based on a suction forceapplied by a suction source to the catheter.

Clause 132: In some examples of the method of any of clauses 124-128,the method further includes controlling, by the control circuitry, thesuction source to cycle the suction force between first and secondsuction forces according to a suction frequency, and wherein determiningthe expansion frequency includes determining the expansion frequencybased on the suction frequency.

Clause 133: In some examples of the method of any of clauses 124-128,the method further includes controlling, by the control circuitry, thesuction force applied by the suction source to the catheter based on acardiac cycle of a patient.

Clause 134: In some examples of the method of any of clauses 124-128,determining the expansion frequency includes determining, by the controlcircuitry, the expansion frequency based on a resonant frequency of athrombus.

Clause 135: In some examples of the method of any of clauses 124-134,the method further including generating, by sensing circuitry, a signalindicative of a cardiac cycle of the patient or a natural frequency of athrombus in vasculature of a patient, wherein determining the expansionfrequency includes determining, by the control circuitry, the expansionfrequency based on the signal from the sensing circuitry.

Clause 136: In some examples of the method of clause 135, the signalincludes at least one of an electrocardiogram, an electrogram, aphotoplethysmogram, or a blood pressure signal.

Clause 137: In some examples of the method of any of clauses 124-136,the expandable member includes a plurality of prongs disposed around thecentral longitudinal axis; and a pull member coupled to at least oneprong of the plurality of prongs, wherein the at least one prong isconfigured to expand radially outward relative to the centrallongitudinal axis in response to a tensile force applied to the pullmember, and wherein controlling the expandable member to move betweenthe expanded configuration and the collapsed configuration based on theexpansion frequency includes controlling an actuation mechanism to applythe tensile force to the pull member based on the expansion frequency.

Clause 138: In some examples of the method of any of clauses 124-137,the expandable member includes a slidable leg configured to moveproximally and distally along a longitudinal axis of the elongated body;a first fixed leg; a second fixed leg, wherein the slidable leg isdisposed between the first and second fixed legs; a strut having a firstend hingedly connected to the slidable leg and a second end hingedlyconnected to the first fixed leg; and a second strut having a third endhingedly connected to the slidable leg and a fourth end hingedlyconnected to the second fixed leg, wherein a proximal motion of theslidable leg relative to the first and second fixed legs causes thefirst and second fixed legs to expand radially outward, and whereincontrolling the expandable member to move between the expandedconfiguration and the collapsed configuration based on the expansionfrequency includes controlling the slidable leg to move proximally anddistally based on the expansion frequency.

Clause 139: In some examples of the method of any of clauses 124-138,the expandable member includes a magnetic material, wherein theexpandable member is configured to expand radially outward or contractradially inward in response to a magnetic force proximate the expandablemember, and wherein controlling the expandable member to move betweenthe expanded configuration and the collapsed configuration based on theexpansion frequency includes controlling a timing with the magneticforce is applied to the expandable member.

Clause 140: In some examples of the method of clause 139, controllingthe timing with which the magnetic force is applied to the expandablemember includes controlling, by the control circuitry, movement of amagnet relative to the expandable member.

Clause 141: In some examples of the method of clause 139, controllingthe timing with which the magnetic force is applied to the expandablemember includes controlling application of energy to a solenoid, thesolenoid being configured to generate the magnetic force.

Clause 142: The method of any of clauses 124-141, wherein the catheterincludes the catheter of any of clauses 92-123 and/or wherein thecontrol circuitry includes the control circuitry of any of clauses92-123.

The examples described herein may be combined in any permutation orcombination.

Various aspects of the disclosure have been described. These and otheraspects are within the scope of the following claims.

What is claimed is:
 1. An aspiration system comprising: a catheterincluding: an elongated body defining an inner lumen; and an expandablemember at a distal portion of the elongated body, wherein the expandablemember is configured to expand radially outward from a contractedconfiguration to an expanded configuration; and control circuitryconfigured to control the expandable member to move between the expandedconfiguration and the contracted configuration based on the expansionfrequency.
 2. The aspiration system of claim 1, wherein the expandedconfiguration is a fully expanded configuration of the expandablemember.
 3. The aspiration system of claim 1, wherein the expandedconfiguration is a partially expanded configuration of the expandablemember.
 4. The aspiration system of claim 1, wherein the contractedconfiguration is a fully contracted configuration of the expandablemember.
 5. The aspiration system of claim 1, wherein the contractedconfiguration is a partially contracted configuration of the expandablemember.
 6. The aspiration system of claim 1, further comprising a userinput device, wherein the control circuitry is configured to receive,via the user input device, user input indicating the expansionfrequency.
 7. The aspiration system of claim 1, wherein the controlcircuitry is configured to determine the expansion frequency.
 8. Theaspiration system of claim 7, wherein the control circuitry isconfigured to determine the expansion frequency based on a cardiac cycleof a patient.
 9. The aspiration system of claim 8, wherein the controlcircuitry is configured to control the expandable member to expandradially outward from the contracted configuration to the expandedconfiguration according to the expansion frequency by at leastcontrolling the expandable member to expand to the expandedconfiguration during a first part of the cardiac cycle and controllingthe expandable member to contract to the contracted configuration duringa second part of the cardiac cycle.
 10. The aspiration system of claim7, further comprising a suction source configured to apply a suctionforce to the catheter to remove fluid from the catheter, wherein thecontrol circuitry is configured to determine the expansion frequencybased on the suction force applied by the suction source to thecatheter.
 11. The aspiration system of claim 10, wherein the controlcircuitry is configured to control the suction source to cycle thesuction force between first and second suction forces according to asuction frequency, and wherein the control circuitry is configured todetermine the expansion frequency based on the suction frequency. 12.The aspiration system of claim 10, wherein the suction source isconfigured to apply a first suction force to the catheter and a secondsuction force to the catheter, wherein the control circuitry isconfigured to control the expandable member to expand radially outwardfrom the contracted configuration to the expanded configurationaccording to the expansion frequency by at least controlling theexpandable member to expand to the expanded configuration when thesuction source is applying the first suction force to the catheter andcontrolling the expandable member to contract to the contractedconfiguration when the suction source is applying the second suctionforce to the catheter.
 13. The aspiration system of claim 10, whereinthe control circuitry is configured to control the suction force appliedby the suction source to the catheter based on a cardiac cycle of apatient.
 14. An aspiration system comprising: a suction sourceconfigured to apply a suction force to a catheter to remove fluid fromthe catheter during a medical aspiration procedure; and controlcircuitry configured to control an expandable member of the catheter toexpand and contract during the medical aspiration procedure.
 15. Theaspiration system of claim 14, wherein the control circuitry isconfigured to control the expandable member to expand and contract by atleast controlling when the expandable member is in a contractedconfiguration and when the expandable member is in an expandedconfiguration based on an expansion frequency.
 16. The aspiration systemof claim 15, wherein the expanded configuration is a fully expandedconfiguration or a partially expanded configuration of the expandablemember.
 17. The aspiration system of claim 15, wherein the contractedconfiguration is a fully contracted configuration or a partiallycontracted configuration of the expandable member.
 18. The aspirationsystem of claim 15, further comprising a user input device, wherein thecontrol circuitry is configured to receive, via the user input device,user input indicating the expansion frequency.
 19. The aspiration systemof claim 15, wherein the control circuitry is configured to determinethe expansion frequency.
 20. The aspiration system of claim 19, furthercomprising sensing circuitry configured to generate a signal indicativeof a cardiac cycle of the patient or a resonant frequency of a thrombusin vasculature of a patient, wherein the control circuitry is configuredto determine the expansion frequency based on the signal.
 21. Theaspiration system of claim 19, wherein the control circuitry isconfigured to determine the expansion frequency based on a suction forceapplied by the suction source to the catheter.
 22. The aspiration systemof claim 19, wherein the control circuitry is configured to determinethe expansion frequency based a resonant frequency of a thrombus. 23.The aspiration system of claim 19, further comprising sensing circuitryconfigured to generate a signal indicative of a cardiac cycle of thepatient or a resonant frequency of a thrombus in vasculature of apatient, wherein the control circuitry is configured to determine theexpansion frequency based on the signal from the sensing circuitry.